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YearIndustryRegulationCustomer categoryProject summary
2026PharmaceuticalcGMPAPI manufacturerSupporting the FDA inspection of API manufacturing facility
2026PharmaceuticalcGMPMedicine manufacturerGAP analys of investigational drug manufacturing facility (cGMP)
2026PharmaceuticalcGMPMedicine manufacturerGAP analys of pharmacutical manufacturing facility (cGMP)
2026PharmaceuticalcGMPMedicine manufacturerGAP analys of pharmacutical manufacturing facility (cGMP)
2026PharmaceuticalCSVAPI manufacturerCSV Consulting
2026PharmaceuticalCSVMedicine manufacturerERES/CSV Training
2026PharmaceuticalGMPAPI manufacturerConsultation on Analytical Method Validation for Developmental Products
2026PharmaceuticalGMPAPI manufacturerGMP Consulting
2026PharmaceuticalGMPMedicine manufacturerBasic Design Review for New Plant Construction
2026PharmaceuticalGMPMedicine manufacturerGMP Improvement Consulting
2026PharmaceuticalGMPMedicine manufacturerQP Mock Inspection of Formulation Plants
2026PharmaceuticalGMPMedicine manufacturerReview of DQ Plans/Reports for New Plant Construction
2026PharmaceuticalGMPMedicine manufacturerReview of IQ/OQ Plans/Reports for New Plant Construction
2026PharmaceuticalGMPMedicine manufacturerSupport for CCS Requirements
2026PharmaceuticalGMPMedicine manufacturerSupport for Improving CSV Procedures
2026PharmaceuticalGMPMedicine manufacturerSupport for Improving Validation Procedures
2026PharmaceuticalGMPMedicine manufacturerSupport for VMP Preparation for New Plant Construction
2026PharmaceuticalGMPPharmaceutical MAHSupport for Validation Strategy Development Regarding Production Line Changes
2026PharmaceuticalGMPRegenerative medicine manufacturerConsultation on Environmental Microorganisms for Aseptic Facilities Review Regarding the Act Against
2026PharmaceuticalGMPRegenerative medicine manufacturerConsultation on Key Audit Points for Selecting Contract Manufacturers (Aseptic)
2026PharmaceuticalGMPRegenerative medicine manufacturerEvaluation of the Adequacy of Manufacturing Records
2026PharmaceuticalGMPRegenerative medicine manufacturerReview of the Verification Plan
2026PharmaceuticalGQPPharmaceutical MAHGQP Training for Regenerative Medicine Products
2026PharmaceuticalOthersCosmetic MAHConsultation on Ensuring Safety of Stem Cell Raw Materials
2026PharmaceuticalOthersMedicine manufacturerSupport for Prefilled Syringe Formulation Development
2026PharmaceuticalPMD ActAPI manufacturerAPI Development Consulting
2026PharmaceuticalPMD ActPharmaceutical MAHDrafting of CTD (M1) Documentation
2026PharmaceuticalPMD ActPharmaceutical MAHQuality Check of CTD (M2, M3)
2026PharmaceuticalPMD ActPharmaceutical MAHSupport for CTD M2 preparation
2026PharmaceuticalPMD ActPharmaceutical MAHSupport for CTD M3 preparation
2026PharmaceuticalPMD ActPharmaceutical MAHSupport for examining anticipated queries and response policies regarding Applications for Marketing Approval
2026PharmaceuticalPMD ActPharmaceutical MAHSupport for responding to query items regarding Applications for Marketing Approval
2026PharmaceuticalPMD ActTrading companyPharmaceutical Regulatory Affairs Training for Trading Companies
2026CosmeticcGMPCosmetic manufacturerGAP analys of pharmacutical manufacturing facility (cGMP)
2026CosmeticEFfCICosmetic ingredient manufacuturerConsulting on EFfCI
2026CosmeticEFfCICosmetic ingredient manufacuturerGAP analysis of cosmetic ingredients factory(EFfCI)
2026CosmeticOthersCosmetic MAHReview Regarding the Act against Unjustifiable Premiums and Misleading Representations
2026CosmeticPMD ActCosmetic MAHReview of Cosmetic Ingredient Labels
2026CosmeticPMD ActQuasi-drug MAHResponding to Inquiries Regarding Quasi-Drug Applications
2026OthersCSVSystem companyCSV Consulting
2026OthersGMPSystem companyTraining for Annual Reviews
2025PharmaceuticalcGMPAPI manufacturerFDA Mock inspection (cGMP)
2025PharmaceuticalcGMPMedicine manufacturerConsultation for establishment of cGMP systems
2025PharmaceuticalcGMPMedicine manufacturerTraining for FDA Inspections
2025PharmaceuticalcGMPPharmaceutical MAHOn-site Facility Investigation for Factory Renovation
2025PharmaceuticalcGMPPharmaceutical MAHSupport for improving issues found for FDA inspections
2025PharmaceuticalcGMPPharmaceutical MAHSupport for improving issues found for FDA inspections
2025PharmaceuticalcGMPPharmaceutical MAHTraining on basic cGMP
2025PharmaceuticalGCPPharmaceutical MAHConsultation for GCP procedure document development
2025PharmaceuticalGCPPharmaceutical MAHProvision of GCP procedure document templates
2025PharmaceuticalGCTPMedicine manufacturerGCTP Procedure Development Support
2025PharmaceuticalGMPAPI manufacturerConsultation on manufacturing control and quality control
2025PharmaceuticalGMPMedicine manufacturerBasic Design Support for New Plant Construction
2025PharmaceuticalGMPMedicine manufacturerConsultation for PV
2025PharmaceuticalGMPMedicine manufacturerConsultation on Cleanliness of API manufacturing facilities
2025PharmaceuticalGMPMedicine manufacturerConsultation on Safety Management of QC Facilities
2025PharmaceuticalGMPMedicine manufacturerConsulting on Purified Water and HVAC Management in China
2025PharmaceuticalGMPMedicine manufacturerDetailed Design Support for New Plant Construction
2025PharmaceuticalGMPMedicine manufacturerGAP analys of pharmacutical manufacturing facility (GMP)
2025PharmaceuticalGMPMedicine manufacturerGAP analysis of GMP procedures
2025PharmaceuticalGMPMedicine manufacturerGMP annual training (3 times in total)
2025PharmaceuticalGMPMedicine manufacturerIQ/OQ Plan Creation Support for New Plant Construction
2025PharmaceuticalGMPMedicine manufacturerIQ/OQ Report Creation Support for New Plant Construction
2025PharmaceuticalGMPMedicine manufacturerIQ/OQ Work Proxy Services for New Plant Construction
2025PharmaceuticalGMPMedicine manufacturerPMDA mock inspection of manufacturing facilities in India
2025PharmaceuticalGMPMedicine manufacturerTraining on Test Skipping
2025PharmaceuticalGMPMedicine manufacturerURS Creation Support for New Plant Construction
2025PharmaceuticalGMPMedicine manufacturerValidation Report Creation Support for New Plant Construction
2025PharmaceuticalGMPMedicine manufacturerVMP Creation Support for New Plant Construction
2025PharmaceuticalGMPPharmaceutical MAHGAP Analysis for Obtaining Pharmaceutical Manufacturing Approval
2025PharmaceuticalGMPPharmaceutical MAHGMP audit training (tablets)
2025PharmaceuticalGMPPharmaceutical MAHOn-site Facility Investigation for Factory Renovation
2025PharmaceuticalGMPPharmaceutical MAHOn-site Facility Investigation for Factory Renovation
2025PharmaceuticalGMPPharmaceutical MAHProxy audits for overseas API manufacturer (GMP)
2025PharmaceuticalGMPPharmaceutical MAHProxy audits for overseas manufacturer (GMP)
2025PharmaceuticalGMPPharmaceutical MAHProxy audits of pharmaceutical manufacture (GMP)
2025PharmaceuticalGMPPharmaceutical MAHProxy audits of pharmaceutical manufacture (GMP)
2025PharmaceuticalGMPPharmaceutical MAHProxy audits of pharmaceutical manufacture (GMP)
2025PharmaceuticalGMPPharmaceutical MAHProxy audits of pharmaceutical manufacture (GMP)
2025PharmaceuticalGMPRegenerative medicine manufacturerSupport for process verification of investigational products
2025PharmaceuticalGMPTrading companyAudit interpretation support for manufacturing facilities in India
2025PharmaceuticalGMPTrading companyGMP audit training for trading company sales staff
2025PharmaceuticalGMPTrading companySupport for proxy audit of API manufacturing sites in China (GMP)
2025PharmaceuticalGMPTrading companySupport for proxy audit of API manufacturing sites in China (GMP)
2025PharmaceuticalGMPTrading companySupport for proxy audit of API manufacturing sites in China (GMP)
2025PharmaceuticalGQPPharmaceutical MAHSupport for License Renewal of MAH
2025PharmaceuticalInvestigational Drug GMPAPI manufacturerProxy audit of manufacturing facilities in China (investigational drugs GMP)
2025PharmaceuticalInvestigational Drug GMPMedicine manufacturerSupport for Establishing GMP Organization for Investigational Medicinal Products
2025PharmaceuticalInvestigational Drug GMPMedicine manufacturerSupport for Establishment of Investigational Medicinal Product GMP Procedures
2025PharmaceuticalInvestigational Drug GMPMedicine manufacturerSupport for Establishment of Investigational Medicinal Product GMP Procedures
2025PharmaceuticalInvestigational Drug GMPPharmaceutical MAHManagement of manufacturing (packaging and labeling) of investigational new drugs
2025PharmaceuticalInvestigational Drug GMPPharmaceutical MAHManufacturing (packaging and labeling) management
2025PharmaceuticalInvestigational Drug GMPPharmaceutical MAHQuality evaluation of imported investigational drug lots
2025PharmaceuticalInvestigational Drug GMPPharmaceutical MAHRevision of product standards for investigational drugs
2025PharmaceuticalInvestigational Drug GMPPharmaceutical MAHSupport for establishment of GMP documentation system for investigational drugs
2025PharmaceuticalInvestigational Drug GMPPharmaceutical MAHSupport for establishment of GMP system for investigational drugs
2025PharmaceuticalInvestigational Drug GMPPharmaceutical MAHSupport for feasibility study on GMP operation for investigational drugs
2025PharmaceuticalInvestigational Drug GMPRegenerative medicine manufacturerQuality system revision support
2025PharmaceuticalOthersMedicine manufacturerConsultation regarding drug containers
2025PharmaceuticalOthersPharmaceutical MAHImport-related services for investigational drugs
2025PharmaceuticalOthersPharmaceutical MAHProxy audit of manufacturing plant for investigational product
2025PharmaceuticalPIC/S GMPMedicine manufacturerConsultation for QP Inspection Preparation
2025PharmaceuticalPIC/S GMPMedicine manufacturerTraining for QP Inspection
2025PharmaceuticalPMD ActFoundationApplication support for Accredetation of Foreign Manufacturer
2025PharmaceuticalPMD ActMedicine manufacturerCMC consulting for pharmaceutical development
2025PharmaceuticalPMD ActMedicine manufacturerConsulting on Pharmaceuticals
2025PharmaceuticalPMD ActMedicine manufacturerSupport for creating MF
2025PharmaceuticalPMD ActPharmaceutical MAHIMPD review for drug submission
2025PharmaceuticalPMD ActPharmaceutical MAHIMPD translation
2025PharmaceuticalPMD ActTrading companyConsulting on APIs
2025Regenerative medicinePIC/S GMPRegenerative medicine manufacturerRegulatory Seminar on Pharmaceuticals and Regenerative Medicine Products in Australia
2025Medical deviceGMPMedical device MAHConsulting on medical devices
2025Medical deviceQMSMedical device MAHProxy audit support for medical device manufacture (QMS)
2025Medical deviceQMSMedical device MAHProxy audit support for medical device manufacture (QMS)
2025Medical deviceQMSMedical device MAHProxy audit support for medical device manufacture (QMS)
2025Medical deviceQMSMedical device manufacturerGAP Analysis of medical device manufacturer (ISO13485)
2025CosmeticcGMPCosmetic ingredient manufacuturercGMP training for API manufacturer
2025CosmeticcGMPCosmetic MAHcGMP training
2025CosmeticcGMPCosmetic MAHSupport for analytical method validation
2025CosmeticcGMPCosmetic MAHSupport for cGMP documentation system
2025CosmeticcGMPCosmetic MAHSupport for cGMP organization establishment
2025CosmeticcGMPCosmetic MAHSupport for cleaning validation
2025CosmeticcGMPCosmetic MAHSupport for improvement of GAP analysis findings
2025CosmeticcGMPCosmetic MAHSupport for PQ, PV
2025CosmeticcGMPCosmetic MAHSupport for qualification of facilities and equipment
2025CosmeticCosmetic GMPCosmetic MAHAudit of packaging, labeling, and storage contractor (Cosmetic GMP)
2025CosmeticCosmetic GMPCosmetic MAHProxy audit of cosmetics storage warehouse (GMP)
2025CosmeticCosmetic GMPCosmetic manufacturerExplanation of ISO 22716 SOP Templates
2025CosmeticCosmetic GMPCosmetic manufacturerISO 22716 GAP analysis
2025CosmeticCosmetic GMPCosmetic manufacturerISO 22716 Training
2025CosmeticCosmetic GMPCosmetic manufacturerMock inspections for ISO22716 certification
2025CosmeticCosmetic GMPCosmetic manufacturerProviding ISO 22716 SOP Templates
2025CosmeticCosmetic GMPCosmetic manufacturerSupport for Creating ISO 22716 SOPs
2025CosmeticCosmetic GMPCosmetic manufacturerSupport for Observation of ISO 22716 Certification Audits
2025CosmeticCosmetic GMPCosmetic manufacturerSupport for Quality System improvements to ISO22716 certification
2025CosmeticCosmetic GMPCosmetic manufacturerSupport for Structural and Facility improvements to ISO22716 certification
2025CosmeticCSVCosmetic MAHSupport for CSV of computerized systems
2025CosmeticPMD ActCosmetic MAHPreliminary investigation for quasi-drug applications
2025CosmeticPMD ActQuasi-drug MAHSupport for preparing documents related to QD registration applications
2025ConstructionCSVConstruction companyCSV training
2025ConstructionGMPConstruction companySupport for creating e-learning GMP educational materials for facility managers
2025EquipmentCSVEquipment sales companySupport for Development of Incubation Equipment
2025EquipmentGMPEquipment sales companyGMP/Validation Training for Equipment Manufacturers
2025EquipmentGMPEquipment sales companyTraining on the Cartagena Act for setting up laboratories
2025EquipmentGMPMedical device manufacturerTraining for Part 11
2025OthersCSVSystem companyCSV Compliance Support for Cell Culture Quality Evaluation Systems
2025OthersCSVSystem companySupport for cell culture quality evaluation systems
2025OthersGCPMedicine manufacturerProxy audits of pharmaceutical development facility (GCP)
2025OthersGMPMedicine manufacturerProxy audits of pharmaceutical manufacture (GMP)
2025OthersGMPMedicine manufacturerProxy audits of pharmaceutical manufacture (GMP)
2025OthersGMPMedicine manufacturerProxy audits of pharmaceutical manufacture (GMP)
2025OthersGMPMedicine manufacturerProxy audits of pharmaceutical manufacture (GMP)
2025OthersGMPMedicine manufacturerProxy audits of pharmaceutical manufacture (GMP)
2025OthersGMPSystem companyGMP training for system suppliers
2025OthersGMPTemporary staffing agencyValidation Training
2025OthersGQPDomestic foundationSeminar on quality control of pharmaceuticals, cosmetics, etc.
2025OthersGQPPharmaceutical MAHProxy audits of pharmaceutical MAH (GQP)
2025OthersGQPPharmaceutical MAHProxy audits of pharmaceutical MAH (GQP)
2025OthersInvestigational Drug GMPEducational corporationSupport for creating clinical trial manufacturing reports
2024PharmaceuticalcGMPAPI manufacturerGAP analys of pharmacutical manufacturing facility (cGMP)
2024PharmaceuticalcGMPPharmaceutical MAHEvaluation of Job Description and Education System
2024PharmaceuticalcGMPPharmaceutical MAHGAP Analysis of API Manufacturer (cGMP)
2024PharmaceuticalCSVSystem companyScope study on the implementation of a production management system
2024PharmaceuticalGMPAPI manufacturerConsultation on Cleaning Validation
2024PharmaceuticalGMPAPI manufacturerConsultation on manufacturing control and quality control
2024PharmaceuticalGMPAPI manufacturerConsultation on sampling methods
2024PharmaceuticalGMPAPI manufacturerGAP analys of pharmacutical manufacturing facility (GMP)
2024PharmaceuticalGMPAPI manufacturerGMP Consulting
2024PharmaceuticalGMPAPI manufacturerGMP Consulting (April-August 2024)
2024PharmaceuticalGMPAPI manufacturerGMP Consulting (Sep 2024-Mar 2025)
2024PharmaceuticalGMPAPI manufacturerSupport for developing a roadmap for acquiring a pharmaceutical (API) manufacturing business
2024PharmaceuticalGMPArchitectural Design CompanySupport for laboratory facility evaluations
2024PharmaceuticalGMPArchitectural Design CompanyTraining for GMP
2024PharmaceuticalGMPDrug discovery companyInitial survey of manufacturing facility (Laboratory)
2024PharmaceuticalGMPDrug discovery companySupport for analyzing the current situation and drafting a Roadmap for development
2024PharmaceuticalGMPMaterial manufacturerConceptual design support for facility improvement
2024PharmaceuticalGMPMaterial manufacturerDesign management improvement support
2024PharmaceuticalGMPMaterial manufacturerGMP organization and document system establishment
2024PharmaceuticalGMPMaterial manufacturerGMP training
2024PharmaceuticalGMPMaterial manufacturerSupport for coordination with customers on quality
2024PharmaceuticalGMPMaterial manufacturerSupport for development of GMP procedures
2024PharmaceuticalGMPMaterial manufacturerSupport for validation of facilities
2024PharmaceuticalGMPMedical device MAHSupport for GMP GAP analysis of QMS system
2024PharmaceuticalGMPMedicine manufacturerGAP analys of pharmacutical manufacturing facility
2024PharmaceuticalGMPMedicine manufacturerGeneral training on GMP
2024PharmaceuticalGMPMedicine manufacturerGeneral training on GMP
2024PharmaceuticalGMPMedicine manufacturerGMP annual training (5 times in total)
2024PharmaceuticalGMPMedicine manufacturerGMP Compliance Investigation of Pharmaceutical Manufacturing Facilities
2024PharmaceuticalGMPMedicine manufacturerGMP training support for education and training personnel
2024PharmaceuticalGMPMedicine manufacturerGroup work for GMP knowledge improvement
2024PharmaceuticalGMPMedicine manufacturerSupport for proxy audit representation of API manufacturing facilities in India
2024PharmaceuticalGMPPharmaceutical MAHAssist in reviewing drawings for pharmaceutical plant renovations
2024PharmaceuticalGMPPharmaceutical MAHAudit interpretation support for pharmaceutical wholesaler warehouses
2024PharmaceuticalGMPPharmaceutical MAHConsultation on Analytical Method Validation
2024PharmaceuticalGMPPharmaceutical MAHConsultation on formulation application
2024PharmaceuticalGMPPharmaceutical MAHConsulting for GMP, QMS, pharmaceutical regulations, etc.
2024PharmaceuticalGMPPharmaceutical MAHGAP Analysis of formulation plants (GMP)
2024PharmaceuticalGMPPharmaceutical MAHGAP Analysis of Injectable Drug Plants (GMP)
2024PharmaceuticalGMPPharmaceutical MAHGMP audit training (API)
2024PharmaceuticalGMPPharmaceutical MAHImprovement plans and responses to reports on issues raised following GMP compliance inspections
2024PharmaceuticalGMPPharmaceutical MAHInterpretation support for audits to select contractors
2024PharmaceuticalGMPPharmaceutical MAHInterpretation support for overseas manufacturing facility audits (English/Japanese)
2024PharmaceuticalGMPPharmaceutical MAHMock inspection (remote) of formulation plants
2024PharmaceuticalGMPPharmaceutical MAHMock inspections of domestic packaging and testing contractors
2024PharmaceuticalGMPPharmaceutical MAHMock inspections of domestic packaging contractors
2024PharmaceuticalGMPPharmaceutical MAHMock inspections of domestic testing contractors
2024PharmaceuticalGMPPharmaceutical MAHOn-site consulting for QC operations
2024PharmaceuticalGMPPharmaceutical MAHPre-audit for API manufacturer in USA (GMP)
2024PharmaceuticalGMPPharmaceutical MAHPre-audit for domestic packaging contractors (GMP)
2024PharmaceuticalGMPPharmaceutical MAHPre-audit for domestic testing contractors (GMP)
2024PharmaceuticalGMPPharmaceutical MAHPre-audit for formulation manufacturer in USA (GMP)
2024PharmaceuticalGMPPharmaceutical MAHPreparation for GMP compliance inspection
2024PharmaceuticalGMPPharmaceutical MAHProxy audits of pharmaceutical manufacture (GMP)
2024PharmaceuticalGMPPharmaceutical MAHProxy audits of starting material manufacturing facilities
2024PharmaceuticalGMPPharmaceutical MAHProxy audits of starting material manufacturing facilities
2024PharmaceuticalGMPPharmaceutical MAHQuality evaluation by inspection of tablets
2024PharmaceuticalGMPPharmaceutical MAHResearch for manufacturing transfer
2024PharmaceuticalGMPPharmaceutical MAHReview of audit results improvement plans and reports
2024PharmaceuticalGMPPharmaceutical MAHReview of product specifications
2024PharmaceuticalGMPPharmaceutical MAHSupport for advance preparation of inquiries for drug manufacturing and marketing approval
2024PharmaceuticalGMPPharmaceutical MAHSupport for drafting instruction
2024PharmaceuticalGMPPharmaceutical MAHSupport for drafting instruction
2024PharmaceuticalGMPPharmaceutical MAHSupport for drafting instruction
2024PharmaceuticalGMPPharmaceutical MAHSupport for drafting instruction
2024PharmaceuticalGMPPharmaceutical MAHSupport for drafting instruction
2024PharmaceuticalGMPPharmaceutical MAHSupport for drafting instruction
2024PharmaceuticalGMPPharmaceutical MAHSupport for drafting instruction
2024PharmaceuticalGMPPharmaceutical MAHSupport for mock inspections of overseas API manufacturers
2024PharmaceuticalGMPPharmaceutical MAHSupport for mock inspections of overseas API manufacturers
2024PharmaceuticalGMPPharmaceutical MAHSupport for mock inspections of overseas formulation manufacturers
2024PharmaceuticalGMPPharmaceutical MAHSupport for mock inspections of overseas formulation manufacturers
2024PharmaceuticalGMPPharmaceutical MAHSupport for proxy audits of manufacturing facilities
2024PharmaceuticalGMPPharmaceutical MAHTraining for GMP compliance inspection
2024PharmaceuticalGMPPharmaceutical MAHTraining of training personnel for GMP education
2024PharmaceuticalGMPRegenerative medicine MAHGMP audit of overseas manufacturing sites (Desktop)
2024PharmaceuticalGMPTrading companyInterpretation for audits of overseas API manufacturing facilities
2024PharmaceuticalGMPTrading companySupport for creation of OOS procedures
2024PharmaceuticalGMPTrading companySupport for proxy audit of API manufacturing sites in China (GMP)
2024PharmaceuticalGQPPharmaceutical MAHSupport for creating procedures for MAH certification
2024PharmaceuticalGQPPharmaceutical MAHSupport for review and finalization of quality contracts
2024PharmaceuticalGQPPharmaceutical MAHSupport for review of procedures related to the manufacture and marketing authorsation of pharmaceutical products
2024PharmaceuticalInvestigational Drug GMPAPI manufacturerSupport for proxy audit of API manufacturing sites in China (Investigational new drug GMP)
2024PharmaceuticalInvestigational Drug GMPPharmaceutical MAHPackaging company's production of investigational drugs is evaluated.
2024PharmaceuticalInvestigational Drug GMPPharmaceutical MAHProxy audits for Investigational New Drug manufacturer(Investigational New Drug GMP)
2024PharmaceuticalInvestigational Drug GMPPharmaceutical MAHSupport for creating investigational product master formula
2024PharmaceuticalInvestigational Drug GMPPharmaceutical MAHSupport for evaluation of suppliers regarding the introduction of investigational new drugs
2024PharmaceuticalInvestigational Drug GMPPharmaceutical MAHSupport for PTP packaging of pharmaceutical products
2024PharmaceuticalInvestigational Drug GMPPharmaceutical MAHSupport for quality assessment of investigational new drugs
2024PharmaceuticalInvestigational Drug GMPPharmaceutical MAHSupport for release decision from overseas manufacturing facilities
2024PharmaceuticalOthersAPI manufacturerConsultation on containment of genotoxic agents
2024PharmaceuticalOthersMedicine manufacturerProxy audits of API Manufacturer (GMP)
2024PharmaceuticalOthersPharmaceutical MAHCMC consultation for development candidates
2024PharmaceuticalOthersPharmaceutical MAHConfirmation of preliminary stability testing results
2024PharmaceuticalOthersPharmaceutical MAHConsultation on policy for MAH certification
2024PharmaceuticalOthersPharmaceutical MAHQuality contract review of overseas manufacturing facilities (APIs and drug product)
2024PharmaceuticalOthersPharmaceutical MAHQuality control of investigational new drugs (up to in-licensing of investigational new drugs)
2024PharmaceuticalOthersPharmaceutical MAHRecruiting Support
2024PharmaceuticalOthersPharmaceutical MAHRegulatory Studies in Asia
2024PharmaceuticalOthersPharmaceutical MAHResearch and training seminars on Chinese laws and regulations
2024PharmaceuticalOthersPharmaceutical MAHSupport for coordination with packaging/testing contractors
2024PharmaceuticalOthersPharmaceutical MAHSupport for development of a proposal for the establishment of a new department
2024PharmaceuticalOthersPharmaceutical MAHSupport for review of quality contracts for domestic manufacturing facilities
2024PharmaceuticalOthersPharmaceutical MAHSupport for Stability Testing
2024PharmaceuticalOthersPharmaceutical MAHSupport for the preparation of preliminary stability testing protocols
2024PharmaceuticalOthersRegenerative medicine MAHReview of quality contracts
2024PharmaceuticalPMD ActFoundationApplication support for Accredetation of Foreign Manufacturer
2024PharmaceuticalPMD ActFoundationSupport for application for approval of the manufacture of specific cellular processed products
2024PharmaceuticalPMD ActPharmaceutical MAHConfirmation and evaluation of stability testing results for PTP packaging and assistance with preliminary stability testing
2024PharmaceuticalPMD ActPharmaceutical MAHConsultation for changes in laboratory test methods
2024PharmaceuticalPMD ActPharmaceutical MAHConsultation for Manufacturing Businesses for Medical Devices
2024PharmaceuticalPMD ActPharmaceutical MAHConsultation for packaging and labeling
2024PharmaceuticalPMD ActPharmaceutical MAHConsultation on OEL and PDE
2024PharmaceuticalPMD ActPharmaceutical MAHConsultation support for CTD preparation (including reporting)
2024PharmaceuticalPMD ActPharmaceutical MAHCTD M1 document draft review support
2024PharmaceuticalPMD ActPharmaceutical MAHPharmaceutical consultation regarding relocation of contractors
2024PharmaceuticalPMD ActPharmaceutical MAHRevew for CTD(M2.3)
2024PharmaceuticalPMD ActPharmaceutical MAHReview of accelerated test results report
2024PharmaceuticalPMD ActPharmaceutical MAHReview of CTD M2.3 and M3
2024PharmaceuticalPMD ActPharmaceutical MAHReview of Drug Approval Applications
2024PharmaceuticalPMD ActPharmaceutical MAHReview of Long-term shelf-life testing result reports
2024PharmaceuticalPMD ActPharmaceutical MAHSuport for translation of CTD
2024PharmaceuticalPMD ActPharmaceutical MAHSupport for CTD M2.3 preparation
2024PharmaceuticalPMD ActPharmaceutical MAHSupport for CTD M3 preparation
2024PharmaceuticalPMD ActPharmaceutical MAHSupport for development of CTD M2.3 and M3 preparation policy
2024PharmaceuticalPMD ActPharmaceutical MAHSupport for obtaining stability test specimens and standards
2024PharmaceuticalPMD ActPharmaceutical MAHSupport for preparation of documentary research materials
2024PharmaceuticalPMD ActPharmaceutical MAHSupport for preparation of stability test protocols
2024PharmaceuticalPMD ActPharmaceutical MAHSupport for proxy audit of testing contractors [Reliability standards].
2024PharmaceuticalPMD ActPharmaceutical MAHSupport for responding to PMDA inquiries (M2.3,M3)
2024PharmaceuticalPMD ActPharmaceutical MAHSupport for scheduling stability tests
2024PharmaceuticalPMD ActPharmaceutical MAHSupport for validation of microbiological tests
2024PharmaceuticalPMD ActPharmaceutical MAHTraining on pharmaceutical affairs
2024PharmaceuticalPMD ActTrading companyConsultation for Master File Creation
2024PharmaceuticalPMD ActTrading companyConsultation support regarding related substances
2024PharmaceuticalPMD ActTrading companyReview of Master File
2024Regenerative medicineGCTPEducational corporationProxy audits of CPC facilities (GCTP)
2024Regenerative medicineGCTPRegenerative medicine MAHConstruction support of regenerative medical product systems
2024Regenerative medicineGCTPRegenerative medicine MAHCreation of trilateral guideline list
2024Regenerative medicineGCTPRegenerative medicine MAHFormulation of development policy for regenerative medical products
2024Regenerative medicineGCTPRegenerative medicine MAHPrepare and provide GCTP procedures
2024Regenerative medicineGCTPRegenerative medicine MAHPrepare and provide GCTP procedures
2024Regenerative medicineGCTPRegenerative medicine MAHSupport for the development of a strategic plan for the management of regenerative medicine products
2024Regenerative medicineGCTPRegenerative medicine MAHSupport for the development of regenerative medicine product management strategies
2024Regenerative medicineInvestigational Drug GMPMedicine manufacturerProxy audits of domestic CPC facilities
2024Regenerative medicineInvestigational Drug GMPRegenerative medicine MAHProxy audit of manufacturing plant for investigational product
2024Regenerative medicineOthersRegenerative medicine MAHSupport for establishment of an organization related to the structure of the clinical trial
2024Regenerative medicineOthersRegenerative medicine MAHSupport for preparation of procedures related to the clinical trial system
2024Regenerative medicineOthersRegenerative medicine MAHTraining on clinical trial structure
2024Regenerative medicineOthersRegenerative medicine manufacturerInvestigation of legal requirements for conducting clinical trials in Australia
2024Regenerative medicinePIC/S GMPRegenerative medicine manufacturerGAP analysis of investigational new drug manufacturing facilities（PIC/S GMP Annex2a）
2024Medical deviceGMPPharmaceutical MAHProxy audit of pharmaceutical manufacturer (GMP)
2024Medical deviceQMSMedical device MAHProxy audit support for medical device warehouses
2024Medical deviceQMSMedical device MAHRevision of risk management SOP's
2024Medical deviceQMSMedical device MAHSupport for creating Usability Engineering Procedures
2024Medical deviceQMSMedical device MAHTraining for risk management
2024Medical deviceQMSMedical device MAHTraining support for SOPs related to QMS
2024CosmeticcGMPCosmetic ingredient manufacuturerGMP Elementary Training Support
2024CosmeticcGMPCosmetic MAHGAP analysis of a cosmetics factory warehouse(cGMP)
2024CosmeticcGMPCosmetic MAHGAP analysis of a cosmetics factory(cGMP)
2024CosmeticcGMPCosmetic MAHGAP analysis of domestic cosmetics manufacturing facilities（cGMP）
2024CosmeticcGMPCosmetic MAHMaking SOP temprate (cGMP)
2024CosmeticcGMPCosmetic MAHSupport for Establishment of GMP Documentation System
2024CosmeticcGMPCosmetic MAHSupport for Establishment of GMP Organization System
2024CosmeticCosmetic GMPCosmetic MAHGAP analysis of a cosmetics factory(ISO22716)
2024CosmeticCosmetic GMPCosmetic MAHGAP analysis of a cosmetics factory(ISO22716)
2024CosmeticEFfCICosmetic ingredient manufacuturerGAP Analysis of Cosmetic Ingredient Manufacturing Facility
2024CosmeticEFfCICosmetic ingredient manufacuturerGAP analysis of cosmetic ingredients factory (ISO9001・EFfCI)
2024CosmeticEFfCICosmetic ingredient manufacuturerSupport for developing a CSV implementation plan for a cosmetics raw materials factory
2024CosmeticEFfCICosmetic ingredient manufacuturerSupport for the development of a structural facility improvement plan for a cosmetics raw materials factory
2024CosmeticEFfCICosmetic ingredient manufacuturerSupport for the development of a structural facility improvement plan for a cosmetics raw materials factory
2024MaterialCSVMaterial manufacturerConfirmation of current system specifications
2024MaterialCSVMaterial manufacturerStudy of systems for additional lines
2024MaterialCSVMaterial manufacturerSupport for business-related IT system studies
2024MaterialCSVMaterial manufacturerSupport for CSV (PQ) of existing IT systems
2024MaterialCSVMaterial manufacturerVendor selection support for IT system implementation
2024MaterialGMPEquipment sales companyTraining support for regulations related to pharmaceutical manufacturing equipment
2024MaterialGMPMaterial manufacturerBasic plan and basic design development for additional lines
2024MaterialGMPMaterial manufacturerDesign support for buildings and building equipment for factory construction
2024MaterialGMPMaterial manufacturerPQ support for existing production facilities
2024MaterialGMPMaterial manufacturerReview of specifications for water facilities
2024MaterialGMPMaterial manufacturerSupport for basic planning of buildings and building facilities
2024MaterialGMPMaterial manufacturerSupport for installation of water facilities
2024MaterialGMPMaterial manufacturerSupport for validation of production facilities (equipment listing and VMP Creation)
2024MaterialGMPMaterial manufacturerURS and DQ support for introduction of water facilities for production
2024MaterialGMPMaterial manufacturerURS and PQ support for production facilities in factory construction
2024MaterialGMPMaterial manufacturerVMP and URS creation support for building facilities in factory construction
2024MaterialOthersMaterial manufacturerConstruction of ISO 15378 related documents
2024MaterialOthersMaterial manufacturerDocumentation support for ISO15378
2024MaterialOthersMaterial manufacturerGAP analysis of documents for ISO 15378 certification
2024ConstructionGMPArchitectural Design CompanyGMP training for pharmaceutical manufacturing plant construction
2024ConstructionGMPConstruction companyTraining about URS
2024ConstructionGMPConstruction companyTraining for CSV
2024ConstructionGMPConstruction companyTraining on Impact Assessment
2024ConstructionGMPConstruction companyValidation Document Review
2024EquipmentCSVEquipment sales companyConsultation for CSV
2024EquipmentCSVEquipment sales companyTraining for CSV
2024EquipmentCSVTrading companyDI support for development systems
2024EquipmentOthersEquipment sales companySupport for test method development
2024OthersCSVSystem companyCSV support for systems
2024OthersGMPPharmaceutical manufacturing component manufacturerGAP analysis of manufacturing facilities for Biopharmaceutical Manufacturing Components (GMP)
2024OthersGMPPharmaceutical manufacturing component manufacturerSupport for improvement plans for findings from audits
2024OthersGMPPublic-service corporationSeminar on Pharmaceutical Quality System
2024OthersGMPSystem companyTraining for CSV
2024OthersOthersSystem companySupport for accompanying the client to check the current status for system proposal
2024OthersQMSLogistics companyWeb consultation on obtaining a medical device manufacturing license, etc.
2023PharmaceuticalcGMPAPI manufacturerCheck deviation/change control, OOS/OOT, and validation records
2023PharmaceuticalcGMPAPI manufacturerFDA Inspection Training
2023PharmaceuticalcGMPAPI manufacturerFDA Mock Inspections for API Plant
2023PharmaceuticalcGMPAPI manufacturerSupport for handling findings during FDA mock inspections
2023PharmaceuticalcGMPAPI manufacturerTraining for cGMP
2023PharmaceuticalcGMPAPI manufacturerTraining for cGMP
2023PharmaceuticalcGMPMedicine manufacturerDeployment/confirmation of job description
2023PharmaceuticalcGMPMedicine manufacturerMock audit of investigational drug manufacturing plant (injectable drug)
2023PharmaceuticalcGMPMedicine manufacturerPrepare/provide training materials for responsible personnel
2023PharmaceuticalcGMPMedicine manufacturerSupport for consideration of education and training management methods
2023PharmaceuticalcGMPMedicine manufacturerTransition to a document management system for training records etc
2023PharmaceuticalcGMPPharmaceutical MAHOrganization/Design of Job Descriptions
2023PharmaceuticalcGMPPharmaceutical MAHOrganization/design of training programs
2023PharmaceuticalcGMPPharmaceutical MAHOrganization/design of training records
2023PharmaceuticalCSVMedicine manufacturerCSV Training
2023PharmaceuticalCSVMedicine manufacturerTraining for CSV guidelines
2023PharmaceuticalGMPAPI manufacturerAudit for Quality Management System for API manufacturer
2023PharmaceuticalGMPAPI manufacturerFDA Mock inspection of API Manufacturer (cGMP)
2023PharmaceuticalGMPAPI manufacturerGMP consulting for API manufacturer
2023PharmaceuticalGMPAPI manufacturerOn-the-job training for self-inspection
2023PharmaceuticalGMPAPI manufacturerProxy audits for overseas API manufacturer (GMP)
2023PharmaceuticalGMPAPI manufacturerProxy audits for overseas API manufacturer (GMP)
2023PharmaceuticalGMPAPI manufacturerProxy audits for overseas API manufacturer (GMP)
2023PharmaceuticalGMPAPI manufacturerProxy audits for overseas API manufacturer (GMP)
2023PharmaceuticalGMPAPI manufacturerProxy audits for overseas API manufacturer (GMP)
2023PharmaceuticalGMPAPI manufacturerSupport for LIMS implementation
2023PharmaceuticalGMPAPI manufacturerTraining for self-inspection
2023PharmaceuticalGMPFoundationPMDA Mock Inspection of Overseas pharmaceutical Manufacturer (GMP)
2023PharmaceuticalGMPMedicine manufacturerConsultation for manufacturing API
2023PharmaceuticalGMPMedicine manufacturerFAT surpport for preparation of pharmaceutical manufacturing plant
2023PharmaceuticalGMPMedicine manufacturerGAP analysis for pharmaceutical manufacturer (GMP)
2023PharmaceuticalGMPMedicine manufacturerProxy audits for overseas manufacturer (GMP)
2023PharmaceuticalGMPMedicine manufacturerProxy audits for Pharmaceutical manufacturer (Investigational Drug GMP)
2023PharmaceuticalGMPMedicine manufacturerResearch support for Reconstruction of pharmaceutical production area
2023PharmaceuticalGMPMedicine manufacturerReview of basic and detailed design documents for the construction of pharmaceutical manufacturing plant
2023PharmaceuticalGMPMedicine manufacturerSupport for aseptic manufacturing area reconstruction layout study
2023PharmaceuticalGMPMedicine manufacturerSupport for DQ plan preparation of pharmaceutical manufacturing plant
2023PharmaceuticalGMPMedicine manufacturerSupport for investigation of estimated cost for reconstruction of the sterile drug product manufacturing area
2023PharmaceuticalGMPMedicine manufacturerSupport for IOQ plan review of pharmaceutical manufacturing plant
2023PharmaceuticalGMPMedicine manufacturerSupport for preparation of architectural URS and VMP for pharmaceutical manufacturing plant
2023PharmaceuticalGMPMedicine manufacturerSupport for preparation of conceptual design for reconstruction of the sterile drug product manufacturing area
2023PharmaceuticalGMPMedicine manufacturerSupport for review of procedures related to DI
2023PharmaceuticalGMPMedicine manufacturerSupport for review of procedures related to education and training
2023PharmaceuticalGMPMedicine manufacturerSupport for survey of current conditions for vector production
2023PharmaceuticalGMPMedicine manufacturerTraining for aseptic formulation（PIC/S ANEEX1）
2023PharmaceuticalGMPMedicine manufacturerTraining for compliance in pharmaceutical manufacturing
2023PharmaceuticalGMPMedicine manufacturerTraining for DI
2023PharmaceuticalGMPMedicine manufacturerTraining for technology transfer
2023PharmaceuticalGMPPharmaceutical MAHComprehensive consulting for pharmaceuticals
2023PharmaceuticalGMPPharmaceutical MAHConsultation on contract manufacturing management
2023PharmaceuticalGMPPharmaceutical MAHEvaluation of manufacturing line drawings for high pharmacological formulation
2023PharmaceuticalGMPPharmaceutical MAHGAP Analysis of Pharmaceutical Manufacturer
2023PharmaceuticalGMPPharmaceutical MAHGMP document inspection
2023PharmaceuticalGMPPharmaceutical MAHGMP document Revision
2023PharmaceuticalGMPPharmaceutical MAHPharmaceutical Affairs consultation on packaging
2023PharmaceuticalGMPPharmaceutical MAHProxy audits for overseas API manufacturer (GMP)
2023PharmaceuticalGMPPharmaceutical MAHProxy audits for overseas manufacturer (GMP)
2023PharmaceuticalGMPPharmaceutical MAHProxy audits for overseas manufacturer (GMP)
2023PharmaceuticalGMPPharmaceutical MAHProxy audits of pharmaceutical manufacture (GMP)
2023PharmaceuticalGMPPharmaceutical MAHReview of CTD
2023PharmaceuticalGMPPharmaceutical MAHReview of validation documents
2023PharmaceuticalGMPPharmaceutical MAHSupport for creating procedures related to manufacturing equipment
2023PharmaceuticalGMPPharmaceutical MAHSupport for research on development data
2023PharmaceuticalGMPPharmaceutical MAHSupport for revision of master batch records
2023PharmaceuticalGMPPharmaceutical MAHVirtual GMP audit training (Sterile Medical Products)
2023PharmaceuticalGMPQuasi-drug MAHConslutation on quasi-drug
2023PharmaceuticalGMPSystem companyGMP Seminar
2023PharmaceuticalGMPTrading companyConsulting on API quantification methods
2023PharmaceuticalGMPTrading companyFirst GMP proxy audit on behalf of API plants in China
2023PharmaceuticalGMPTrading companyPeriodic GMP proxy audit on behalf of API plants in China
2023PharmaceuticalGMPTrading companyProxy audit of API Manufacturing Facility in India (GMP)
2023PharmaceuticalGMPTrading companySelf-inspection at warehouse facilities(Packaging, labeling, storage)
2023PharmaceuticalGQPPharmaceutical MAHReferral assistance for General Marketing compliance Officer
2023PharmaceuticalGVPPharmaceutical MAHSales of GVP procedures
2023PharmaceuticalInvestigational Drug GMPMedicine manufacturerConsultation on investigational drug stability testing
2023PharmaceuticalInvestigational Drug GMPMedicine manufacturerConsultation on manufacturing of APIs for clinical trials
2023PharmaceuticalInvestigational Drug GMPPharmaceutical MAHAudit of packaging contractors for investigational new drugs
2023PharmaceuticalInvestigational Drug GMPPharmaceutical MAHEvaluation of Investigational New Drug Supplier
2023PharmaceuticalInvestigational Drug GMPPharmaceutical MAHExamination of domestic packaging and labeling specifications for investigational new drug
2023PharmaceuticalInvestigational Drug GMPPharmaceutical MAHInvestigational new drug transport mode study
2023PharmaceuticalInvestigational Drug GMPPharmaceutical MAHManagement of importation and storage of pharmaceutical products on behalf of the company
2023PharmaceuticalInvestigational Drug GMPPharmaceutical MAHManagement of packaging, storage, and delivery of investigational drugs on behalf of the company
2023PharmaceuticalInvestigational Drug GMPPharmaceutical MAHPreparation of documents related to the investigational new drug
2023PharmaceuticalInvestigational Drug GMPPharmaceutical MAHPreparation of Quality Arrangements
2023PharmaceuticalInvestigational Drug GMPPharmaceutical MAHQuality Assessment of Investigational New drug
2023PharmaceuticalInvestigational Drug GMPPharmaceutical MAHQuality control operations on behalf of the company
2023PharmaceuticalInvestigational Drug GMPPharmaceutical MAHSupport for establishment of procedures for investigational new drugs GMP
2023PharmaceuticalOthersPharmaceutical MAHConsultation for pharmaceutical business
2023PharmaceuticalPMD ActPharmaceutical MAHConsultation and evaluation of PTP sheets
2023PharmaceuticalPMD ActPharmaceutical MAHConsultation for contract laboratory
2023PharmaceuticalPMD ActPharmaceutical MAHConsultation on product labels for pharmaceutical Drug Product
2023PharmaceuticalPMD ActPharmaceutical MAHPharmaceutical Affairs Consultation for Excipients
2023PharmaceuticalPMD ActPharmaceutical MAHPharmaceutical consultation for drug additives
2023PharmaceuticalPMD ActPharmaceutical MAHPharmaceutical consultation for reference material
2023PharmaceuticalPMD ActPharmaceutical MAHSupport for FD application data review
2023PharmaceuticalPMD ActPharmaceutical MAHSupport for pharmaceutical consultation regarding M1.2
2023PharmaceuticalPMD ActPharmaceutical MAHSupport for responding to PMDA inquiries
2023Medical deviceCSVMedical device manufacturerSupport for creation of CSV-related business standards
2023Medical deviceOthersMedical device MAHConsultation for GLP
2023Medical devicePMD ActMedical device MAHSupport for preparation of application for patical changes documents
2023Medical deviceQMSMedical device MAHConsultation for Revised QMS Regulations
2023Medical deviceQMSMedical device MAHConsultation for vaccine filling facilities
2023Medical deviceQMSMedical device MAHOn-site consulting for QA operations
2023Medical deviceQMSMedical device MAHOn-site consulting for QA operations
2023Medical deviceQMSMedical device MAHReview of revised procedures regarding QMS
2023Medical deviceQMSMedical device MAHSelf-inspection of medical device MAH
2023Medical deviceQMSMedical device MAHSelf-inspection of medical device manufacturers (QMS)
2023Medical deviceQMSMedical device MAHSupport for QMS document review
2023Medical deviceQMSPharmaceutical MAHPreparation support for medical device MAH update audits
2023CosmeticcGMPCosmetic ingredient manufacuturerFDA Inspection Interpreter (Japanese/English)
2023CosmeticcGMPCosmetic ingredient manufacuturerGAP analysis for API manufacturer (cGMP)
2023CosmeticcGMPCosmetic ingredient manufacuturerGAP analysis for API manufacturer (cGMP)
2023CosmeticcGMPCosmetic ingredient manufacuturerGMP trainning for API manufacturer
2023CosmeticcGMPCosmetic ingredient manufacuturerSupport for preparation for FDA inspection
2023CosmeticcGMPCosmetic ingredient manufacuturerSupport for response to FDA findings (Form 483)
2023CosmeticcGMPCosmetic ingredient manufacuturerSupporting the FDA inspection of API manufacturing facility
2023CosmeticCosmetic GMPQuasi-drug MAHProxy audit of Cosmetics Manufacturer (Cosmetic GMP)
2023CosmeticOthersCosmetic MAHConsultation on OTC drugs for the U.S.
2023MaterialGMPEquipment sales companyValidation consulting for equipment manufacturer
2023MaterialGMPMaterial manufacturerConcept design and planning support for new facility construction
2023MaterialOthersMaterial manufacturerReview of product specifications
2023EquipmentCSVSystem companyTraining for Validation/CSV implementation
2023EquipmentGMPEquipment sales companyTraining for equipment manufacturers about validation
2023EquipmentGMPEquipment sales companyTraining for equipment manufacturers about validation
2023EquipmentGMPEquipment sales companyValidation consulting for equipment manufacturer
2023OthersCSVSystem companyCSV support for production management systems
2023OthersGCPMedicine manufacturerProxy audits of pharmaceutical development facility (GCP)
2023OthersGMPMedicine manufacturerProxy audits of pharmaceutical manufacture (GMP)
2023OthersGMPMedicine manufacturerProxy audits of pharmaceutical manufacture (GMP)
2023OthersGMPMedicine manufacturerProxy audits of pharmaceutical manufacture (GMP)
2023OthersGQPMedicine manufacturerProxy audits of pharmaceutical MAH (GQP)
2023OthersGQPPharmaceutical MAHCreation of audit checklist (GMP)
2023当局対応GMPPharmaceutical MAHSupport for responding to PMDA inquiries
2022PharmaceuticalcGMPMedicine manufacturerGAP analysis for laboratories (cGMP)
2022PharmaceuticalcGMPMedicine manufacturerSupport for evaluation of cGMP compliance for export of investigational API to the U.S.
2022PharmaceuticalCSVAPI manufacturerAdvice for warehouse management system installation
2022PharmaceuticalCSVMedicine manufacturerCreation of URS
2022PharmaceuticalCSVMedicine manufacturerCreation of Validation Master Plan
2022PharmaceuticalCSVMedicine manufacturerCSV report preparation
2022PharmaceuticalCSVMedicine manufacturerDQ surpport
2022PharmaceuticalCSVMedicine manufacturerFAT surpport
2022PharmaceuticalCSVMedicine manufacturerIQ/OQ surpport
2022PharmaceuticalCSVPharmaceutical MAHReview of system specifications for installation of a scratch system
2022PharmaceuticalCSVPharmaceutical MAHSupport for DQ review of scratch system implementation
2022PharmaceuticalCSVPharmaceutical MAHSupport for IQ review scratch system implementation
2022PharmaceuticalCSVPharmaceutical MAHSupport for OQ review scratch system implementation
2022PharmaceuticalCSVPharmaceutical MAHSupport for review of validation plan for scratch system implementation
2022PharmaceuticalCSVPharmaceutical MAHURS Review for Scratch System Installation
2022PharmaceuticalCSVPharmaceutical MAHURS review support for scratch system implementation
2022PharmaceuticalCSVSystem companyCSV training for system vendors
2022PharmaceuticalGMPAPI manufacturerGAP analysis of API manufacturer (GMP)
2022PharmaceuticalGMPAPI manufacturerGMP Consulting
2022PharmaceuticalGMPAPI manufacturerGMP training
2022PharmaceuticalGMPAPI manufacturerSupport for cleaning validation of common equipment
2022PharmaceuticalGMPAPI manufacturerSupport for establishment of pharmaceutical quality system
2022PharmaceuticalGMPAPIs intermediates manufacturerGMP consulting for API intermediate manufacturer
2022PharmaceuticalGMPFoundationPMDA Mock Inspection of Overseas Biological Drug Manufacturing Sites
2022PharmaceuticalGMPMedical device MAHOrganize requirements for setting up a GMP manufacturing facility
2022PharmaceuticalGMPMedical device MAHOrganizing requirements for pharmaceutical manufacturing applications (GCTP)
2022PharmaceuticalGMPMedicine manufacturerCAPA Plan Review of GAP Analysis Findings
2022PharmaceuticalGMPMedicine manufacturerConsultation for Reference Standard
2022PharmaceuticalGMPMedicine manufacturerCreation of Validation Master Plan
2022PharmaceuticalGMPMedicine manufacturerGAP analysis of GMP procedures
2022PharmaceuticalGMPMedicine manufacturerGAP analysis of pharmaceutical Manufacturer (EU GMP)
2022PharmaceuticalGMPMedicine manufacturerGMP training
2022PharmaceuticalGMPMedicine manufacturerInstruction on equipment calibration and periodic inspections
2022PharmaceuticalGMPMedicine manufacturerInterpretation support for pharmaceutical-related business
2022PharmaceuticalGMPMedicine manufacturerProxy audits of API Manufacturer (GMP)
2022PharmaceuticalGMPMedicine manufacturerProxy for paper audit (GMP)
2022PharmaceuticalGMPMedicine manufacturerProxy for paper audit of overseas API manufacturer (GMP)
2022PharmaceuticalGMPMedicine manufacturerSupport for environmental validation documentation and execution
2022PharmaceuticalGMPMedicine manufacturerSupport for PQ documentation and execution of equipment and facilities
2022PharmaceuticalGMPMedicine manufacturerSupport for preparation of tertiary documents related for GMP
2022PharmaceuticalGMPMedicine manufacturerSupport for revalidation of relocated equipments
2022PharmaceuticalGMPMedicine manufacturerSupport for SOP restructuring study (GMP)
2022PharmaceuticalGMPMedicine manufacturerSupport for sterilization validation documentation and execution
2022PharmaceuticalGMPMedicine manufacturerSupport for temperature mapping documentation and execution
2022PharmaceuticalGMPMedicine manufacturerSupport forGrowth Promotion Test documentation and execution
2022PharmaceuticalGMPMedicine manufacturerSupport the creation of Transport Verification documentationand execution
2022PharmaceuticalGMPPharmaceutical MAHInterpretation for PMDA remote inspections of overseas API manufacturer
2022PharmaceuticalGMPPharmaceutical MAHInterpretation for PMDA remote inspections of overseas API manufacturing sites
2022PharmaceuticalGMPPharmaceutical MAHProxy audits of pharmaceutical manufacture (GMP)
2022PharmaceuticalGMPPharmaceutical MAHSupport on supplier audits of scratch system implementation
2022PharmaceuticalGMPPharmaceutical MAHTraining about MF
2022PharmaceuticalGMPTrading companyGMP Training for Management
2022PharmaceuticalGMPTrading companyProxy audits for overseas API manufacturer (GMP)
2022PharmaceuticalGMPTrading companyTraining of management on pharmaceutical quality systems
2022PharmaceuticalInvestigational Drug GMPMedicine manufacturerDevelopment support in investigational drug manufacturing
2022PharmaceuticalInvestigational Drug GMPMedicine manufacturerGAP Analysis (Investigational Drug GMP)
2022PharmaceuticalInvestigational Drug GMPMedicine manufacturerProxy audit of investigational drug manufacturer (Investigational Drug GMP)
2022PharmaceuticalOthersAPI manufacturerSupport for registration with the U.S. DMF
2022PharmaceuticalOthersMedicine manufacturerSerialization Overview Training
2022PharmaceuticalOthersPharmaceutical MAHConsultation for contamination with foreign materials
2022PharmaceuticalPMD ActMedical device MAHEvaluation of Elemental Impurities
2022PharmaceuticalPMD ActPharmaceutical MAHConsultation for tablet imprinting
2022PharmaceuticalPMD ActPharmaceutical MAHMaking MF draft
2022PharmaceuticalPMD ActRegenerative medicine MAHSupport for evaluation of elemental impurities (ICH Q3D)
2022PharmaceuticalPMD ActTrading companyInvestigation to set specifications
2022Regenerative medicineGCPRegenerative medicine MAHInvestigation of the current status of regenerative medicine product development data
2022Regenerative medicineGCPRegenerative medicine MAHSupport for compilation of development data
2022Regenerative medicineGCPRegenerative medicine MAHSupport for compiling data to determine manufacturing process
2022Regenerative medicineGCPRegenerative medicine MAHSupport for compiling data to determine test criteria and methods
2022Regenerative medicineGCPRegenerative medicine MAHSupport for Risk Assessment
2022Regenerative medicineGCPRegenerative medicine MAHTechnical training on development
2022Regenerative medicineGCPRegenerative medicine MAHTraining for Drug Product Development
2022Regenerative medicineGCTPEducational corporationDocumentation Support (GCTP)
2022Regenerative medicineGCTPRegenerative medicine MAHInvestigation into the current status of quality assurance for shipments of regenerative medicine products
2022Regenerative medicineGCTPRegenerative medicine MAHRecord review for shipments of regenerative medicine products
2022Regenerative medicineGCTPRegenerative medicine manufacturerBasic design support for CPC construction
2022Regenerative medicineGCTPRegenerative medicine manufacturerBasic planning support for CPC construction
2022Regenerative medicineGCTPRegenerative medicine manufacturerDetailed design support for CPC construction
2022Regenerative medicineGCTPRegenerative medicine manufacturerSupport in organizing manufacturing and test processes for CPC construction
2022Regenerative medicineGMPRegenerative medicine MAHAdvise of PQ for factory build out
2022Regenerative medicineGMPRegenerative medicine MAHInitial GMP training for manufacturing regenerative medicine products
2022Regenerative medicineGMPRegenerative medicine MAHInvestigation of regenerative medical product manufacturing facilities
2022Regenerative medicineGMPRegenerative medicine MAHIQ/OQ documentation for factory build out
2022Regenerative medicineGMPRegenerative medicine MAHOrganize requirements and prepare UR for factory build-out
2022Regenerative medicineGMPRegenerative medicine MAHPreparation of DQ for factory build out
2022Regenerative medicineGMPRegenerative medicine MAHProxy audit of intermediate manufacturing plant for regenerative medicine combination products
2022Regenerative medicineGMPRegenerative medicine MAHReview of basic design for factory build out
2022Regenerative medicineGMPRegenerative medicine MAHReview of detailed design for factory build out
2022Regenerative medicineGMPRegenerative medicine MAHSupport for determination of quality requirements for manufacturers of intermediates of combination products for regenerative medicine
2022Regenerative medicineGMPRegenerative medicine MAHSupport for GMP document development for manufacturing of regenerative medicine products
2022Regenerative medicineGMPRegenerative medicine MAHSupport for improvement of manufacturing facilities for regenerative medical products
2022Regenerative medicineGMPRegenerative medicine MAHTechnical training on GMP
2022Regenerative medicineGMPRegenerative medicine MAHValidation Implementation Status Investigation for Manufacturing and Testing Facilities
2022Regenerative medicineGMPRegenerative medicine MAHVMP and URS preparation for factory build out
2022Regenerative medicineInvestigational Drug GMPEducational corporationBasic traning of Investigational Drug GMP
2022Regenerative medicineInvestigational Drug GMPEducational corporationExplanation of GMP PQS Procedures of Investigational New Drugs for Physician-Initiated Clinical Trials
2022Regenerative medicineInvestigational Drug GMPEducational corporationReview of investigational drug manufacturing docymentented manufactuuring orders for investigator-initiated clinical trials
2022Regenerative medicineInvestigational Drug GMPEducational corporationSupport for creating a template for creating procedure manuals (Investigational Drug GMP)
2022Regenerative medicineInvestigational Drug GMPEducational corporationSupport for development of investigational drug GMP documents for investigator-initiated clinical trials
2022Regenerative medicineInvestigational Drug GMPEducational corporationSupport for establishment of investigational drug GMP organization for investigator-initiated clinical trials
2022Regenerative medicineInvestigational Drug GMPRegenerative medicine MAHSupport for determination of in-process testing and quality test criteria
2022Regenerative medicineInvestigational Drug GMPRegenerative medicine MAHSupport for investigational drug manufacturing
2022Regenerative medicineInvestigational Drug GMPRegenerative medicine MAHSupport for preparation of investigational drug product master formula
2022Regenerative medicineInvestigational Drug GMPRegenerative medicine MAHSupport for Test Method Validation
2022Regenerative medicineOthersDrug discovery companySupport for licensing out of pharmaceutical products
2022Regenerative medicinePMD ActRegenerative medicine MAHInvestigate regenerative medicine combination product development data
2022Regenerative medicinePMD ActRegenerative medicine MAHInvestigation of the current status of regenerative medicine product development data
2022Regenerative medicineQMSRegenerative medicine MAHGAP Analysis (QMS)
2022Medical deviceCSVMedical device MAHCreate and review IQ reports for warehouse management system installation
2022Medical deviceCSVMedical device MAHCreate and review OQ plan for warehouse management system installation
2022Medical deviceCSVMedical device MAHCreate and review OQ reports for warehouse management system installation
2022Medical deviceCSVMedical device MAHCreation of URS for QMS management system upgrade
2022Medical deviceCSVMedical device MAHCreation of URS for QMS management system upgrade
2022Medical deviceCSVMedical device MAHDQ/IQ/OQ document review for QMS management system upgrades
2022Medical deviceCSVMedical device MAHDQ/IQ/OQ document review for QMS management system upgrades
2022Medical deviceCSVMedical device MAHDrafting of operational management procedures for warehouse management system installation
2022Medical deviceCSVMedical device MAHOrganize draft operating procedures for warehouse management system installation
2022Medical deviceCSVMedical device MAHPerforming PQ for warehouse management system installation
2022Medical deviceCSVMedical device MAHPQ documentation and PQ implementation for QMS management system upgrade
2022Medical deviceCSVMedical device MAHPQ documentation and PQ implementation for QMS management system upgrade
2022Medical deviceCSVMedical device MAHPQ plan drafting for warehouse management system installation
2022Medical deviceCSVMedical device MAHPQ scenario and script drafting for warehouse management system installation
2022Medical deviceCSVMedical device MAHPrepared validation report for warehouse management system installation
2022Medical deviceCSVMedical device MAHValidation plan drafting for QMS management system upgrade
2022Medical deviceCSVMedical device MAHValidation plan drafting for QMS management system upgrade
2022Medical deviceCSVMedical device MAHValidation report preparation for QMS management system upgrade
2022Medical deviceCSVMedical device MAHValidation report preparation for QMS management system upgrade
2022Medical deviceCSVMedical device manufacturerSupport for CSV document development
2022Medical deviceCSVMedical device manufacturerSupport for policy discussions for CSV document development
2022Medical deviceCSVMedical device manufacturerSupport for SOP creation related to CSV
2022Medical deviceCSVMedical device manufacturerSupport for the discussion of policies for the development of CSV documentation
2022Medical deviceOthersMedical device MAHSupport for Stability testing
2022Medical deviceQMSCosmetic MAHProxy audit of medical device storage contractor (QMS)
2022Medical deviceQMSMedical device MAHSupport for determination of quality requirements for manufacturer of combination products for regenerative medicine etc.
2022Medical deviceQMSMedical device MAHSupport for QMS improvement
2022CosmeticcGMPCosmetic ingredient manufacuturercGMP consulting for API manufacturer
2022CosmeticcGMPCosmetic ingredient manufacuturercGMP training for API manufacturer
2022CosmeticCosmetic GMPCosmetic MAHProxy audit of cosmetics storage contractor（Cosmetic GMP）
2022CosmeticCosmetic GMPCosmetic MAHProxy audit（Cosmetic GMP）
2022CosmeticCosmetic GMPMaterial manufacturerProxy audit of cosmetics storage contractor（Cosmetic GMP）
2022CosmeticEFfCICosmetic ingredient manufacuturerEFfCI GMP Improvement Consulting for Cosmetics Manufacturer
2022CosmeticEFfCICosmetic ingredient manufacuturerGAP Analysis of Cosmetic Ingredient Manufacturing Plant (EFfCI GMP)
2022CosmeticEFfCICosmetic ingredient manufacuturerSupport for review of proposed product filling room modifications
2022CosmeticPMD ActMedical device MAHInvestigation to apply for permission to use colorants in Japan
2022MaterialGMPMaterial manufacturerCreate and review master batch records
2022MaterialGMPMaterial manufacturerCreation of roadmap for validation (GMP)
2022MaterialGMPMaterial manufacturerCreation of Validation Master Plan
2022MaterialGMPMaterial manufacturerGAP Analysis for Material Manufacturing Plants (GMP)
2022MaterialGMPMaterial manufacturerInvestigation of the current status of validation
2022MaterialGMPMaterial manufacturerProvide a validation procedure template
2022MaterialGMPMaterial manufacturerReview of IOQ Plan/Report
2022MaterialGMPMaterial manufacturerReview of PQ Plan/Report
2022MaterialGMPMaterial manufacturerReview of PV Plan/Report
2022MaterialGMPMaterial manufacturerSupport for preliminary study of equipment and facilities for new factory
2022MaterialGMPMaterial manufacturerSupport for preliminary study of manufacturing process
2022MaterialGMPMaterial manufacturerSupport for preliminary study of packaging specifications
2022ConstructionGMPConstruction companyEngineering support for warehouse construction
2022EquipmentCSVEquipment sales companyConsultation on CSV support for image inspection equipment (GMP)
2022EquipmentCSVEquipment sales companyProvide ER/ES and Part 11 checklists
2022EquipmentCSVEquipment sales companyProvide supplier written audit list in CSV for imaging inspection equipment
2022EquipmentQMSEquipment sales companySupport for consultation on validation of imaging inspection equipment
2022EquipmentQMSEquipment sales companySupport for creation of validation documentation for imaging inspection equipment (DQ, IQ, OQ)
2022EquipmentQMSEquipment sales companySupport for Validation Document Review of Imaging and Inspection Equipment (DQ)
2022EquipmentQMSEquipment sales companyValidation training for equipment suppliers
2022OthersCSVClinical laboratory testing companyCSV document drafting for installation of maintenance management system
2022OthersCSVClinical laboratory testing companyCSV document review for maintenance management system installation
2022OthersGMPAnalysis companyGAP analysis of laboratory (GMP)
2022OthersGMPEvent companyDI Seminar
2021PharmaceuticalcGMPAPI manufacturercGMP consulting
2021PharmaceuticalcGMPMedicine manufacturerGAP analysis for pharmaceutical manufacturer (cGMP)
2021PharmaceuticalcGMPPharmaceutical MAHcGMP consulting for API manufacturer
2021PharmaceuticalCSVMedicine manufacturerConsulting for system implementation
2021PharmaceuticalCSVMedicine manufacturerCSV consulting (GMP)
2021PharmaceuticalGDPCertification bodySeminar of GDP
2021PharmaceuticalGMPAPI manufacturerConfirmation for CAPA plan (GMP)
2021PharmaceuticalGMPAPI manufacturerGMP consulting for API manufacturer
2021PharmaceuticalGMPAPI manufacturerProxy audits of starting material manufacturing facilities
2021PharmaceuticalGMPFoundationJ-GMP Seminar for Overseas Pharmaceutical Manufacturers
2021PharmaceuticalGMPMedicine manufacturerBasic design support for the construction of an injectable drug manufacturing plant
2021PharmaceuticalGMPMedicine manufacturerConceptual design review for the construction of a pre-filled syringe manufacturing line
2021PharmaceuticalGMPMedicine manufacturerConceptual design support for construction of an injectable drug manufacturing plant
2021PharmaceuticalGMPMedicine manufacturerConsultation for Validation of Packaging
2021PharmaceuticalGMPMedicine manufacturerConsultation of microbial control (GMP)
2021PharmaceuticalGMPMedicine manufacturerDetailed design review of pre-filled syringe manufacturing line installation
2021PharmaceuticalGMPMedicine manufacturerDetailed design support for the construction of an injectable drug manufacturing plant
2021PharmaceuticalGMPMedicine manufacturerEvaluation of microbial control (GMP)
2021PharmaceuticalGMPMedicine manufacturerFeasibility study support for the construction of an injection drug manufacturing plant
2021PharmaceuticalGMPMedicine manufacturerGAP Analysis of Pharmaceutical Manufacturer (GMP)
2021PharmaceuticalGMPMedicine manufacturerGAP Analysis of Pharmaceutical Manufacturer (GMP)
2021PharmaceuticalGMPMedicine manufacturerGMP training
2021PharmaceuticalGMPMedicine manufacturerGMP training
2021PharmaceuticalGMPMedicine manufacturerProxy audits for pharmaceutical manufacturer (GMP)
2021PharmaceuticalGMPMedicine manufacturerProxy audits for pharmaceutical manufacturer (GMP)
2021PharmaceuticalGMPMedicine manufacturerProxy audits of API Manufacturer (GMP)
2021PharmaceuticalGMPMedicine manufacturerReview of basic design for pre-filled syringe manufacturing line installation
2021PharmaceuticalGMPMedicine manufacturerReview of layout design (GMP)
2021PharmaceuticalGMPMedicine manufacturerReview of SOP (GMP)
2021PharmaceuticalGMPMedicine manufacturerSupport for improving manufacturing records (GMP)
2021PharmaceuticalGMPPharmaceutical MAHConfirmation of the current status of the PQS at the injectable manufacturing plant（GMP）
2021PharmaceuticalGMPPharmaceutical MAHGAP analysis for pharmaceutical manufacturer (GMP)
2021PharmaceuticalGMPPharmaceutical MAHGAP analysis for pharmaceutical manufacturer (GMP)
2021PharmaceuticalGMPPharmaceutical MAHProxy audit of Pharmaceutical Manufacturer (GMP)
2021PharmaceuticalGMPPharmaceutical MAHProxy audits for pharmaceutical manufacturer (GMP)
2021PharmaceuticalGMPPharmaceutical MAHSupport for preparation of formats for paper-based GMP audits
2021PharmaceuticalGMPReagent Manufacturing and Sales CompanyReview of analytical procedure validation protocols (GMP)
2021PharmaceuticalGMPTrading companySelling SOPs
2021PharmaceuticalGMPTrading companySupport for preparation of formats for paper-based GMP audits
2021PharmaceuticalGMPTrading companyTraining of GMP audit
2021PharmaceuticalGQPTrading companyGQP consulting
2021PharmaceuticalInvestigational Drug GMPAPI manufacturerConfirmation for CAPA plan (Investigational Drug GMP)
2021PharmaceuticalInvestigational Drug GMPDrug discovery companyInvestigational Drug GMP consulting
2021PharmaceuticalInvestigational Drug GMPDrug discovery companyInvestigational Drug GMP consulting
2021PharmaceuticalInvestigational Drug GMPDrug discovery companyReview of SOP (GMP)
2021PharmaceuticalInvestigational Drug GMPMedicine manufacturerProxy audits for overseas investigational drug manufacturer (Investigational Drug GMP)
2021PharmaceuticalInvestigational Drug GMPPharmaceutical MAHConfirmation for CAPA plan (Investigational Drug GMP)
2021PharmaceuticalPMD ActFoundationApplication support for Accredetation of Foreign Manufacturer
2021PharmaceuticalPMD ActPharmaceutical MAHConsultation for change of Critical Control Parameter
2021PharmaceuticalPMD ActPharmaceutical MAHConsultation for Stability Testing
2021PharmaceuticalQMSEvent companyCSA seminar
2021Regenerative medicineGCTPEducational corporationSupport for revision of SOPs (GCTP)
2021Regenerative medicineGCTPRegenerative medicine MAHGCTP consulting
2021Regenerative medicineGCTPRegenerative medicine MAHProxy audits of regenerative medicine products Manufacturer (GCTP)
2021Regenerative medicineInvestigational Drug GMPEducational corporationSOP's and record review for regenerative medicine products
2021Regenerative medicineOthersMedical device MAHInvestigation of development data for regenerative medicine combination products
2021Regenerative medicineQSRMedical device MAHGAP analysis in the development of regenerative medicine combination products
2021Regenerative medicineQSRMedical device MAHInvestigation of regenerative medicine combination product development data for export to the U.S.
2021Medical deviceCSVMedical device MAHCSV consultation for warehouse management system installation
2021Medical deviceCSVMedical device MAHCSV consultation for warehouse management system installation
2021Medical deviceCSVMedical device MAHCSV verification for ERP installation
2021Medical deviceCSVMedical device MAHProject promotion support for warehouse management system installation
2021Medical deviceCSVMedical device MAHReview of vendor specifications for ERP system installation
2021Medical deviceCSVMedical device MAHVerification of ERP system installation
2021Medical deviceQMSMedical device MAHConstruction support of QMS system
2021Medical deviceQMSMedical device MAHConstruction support of QMS system
2021Medical deviceQMSMedical device MAHExplanation of QMS overview
2021Medical deviceQMSMedical device MAHReview of layout design (QMS)
2021Medical deviceQMSMedical device MAHReview of PQ protocol (QMS)
2021Medical deviceQMSMedical device MAHReview of PQ protocol (QMS)
2021Medical deviceQMSMedical device MAHReview of PQ report (QMS)
2021Medical deviceQMSMedical device MAHSupport for QMS Organization Establishment
2021CosmeticcGMPCosmetic ingredient manufacuturerAdvice for CAPA plan (cGMP)
2021CosmeticcGMPCosmetic ingredient manufacuturercGMP training
2021CosmeticcGMPCosmetic ingredient manufacuturerConfirmation of improvement status (cGMP)
2021CosmeticcGMPCosmetic ingredient manufacuturerConsulting on item addition (cGMP)
2021CosmeticcGMPCosmetic ingredient manufacuturerCSV consulting (cGMP)
2021CosmeticcGMPCosmetic ingredient manufacuturerReview of CAPA plan (cGMP)
2021CosmeticCosmetic GMPCosmetic manufacturerGAP Analysis (Cosmetic GMP)
2021MaterialGMPMaterial manufacturerConsultation for Construction of Rubber Plug Manufacturing Plant
2021MaterialGMPMaterial manufacturerGMP training
2021MaterialGMPMaterial manufacturerInvestigations of the current plant for the construction of a new plant
2021MaterialGMPMaterial manufacturerSupport for preliminary study of equipment and facilities for new factory
2021MaterialGMPMaterial manufacturerSupport for preliminary study of manufacturing process
2021MaterialGMPMaterial manufacturerSupport for preliminary study of packaging specifications
2021ConstructionCSVConstruction companyCSV document review and meetings for warehouse construction
2021ConstructionGMPConstruction companyBasic design support for the construction of an injectable drug manufacturing plant
2021ConstructionGMPConstruction companyCompetition support as an inner consultant (GMP)
2021ConstructionGMPConstruction companyDesign review and meeting regarding warehouse construction (GMP)
2021ConstructionGMPConstruction companyDetailed design support for the construction of an injectable drug manufacturing plant
2021ConstructionGMPConstruction companyIOQ document review and meetings regarding warehouse construction
2021ConstructionGMPConstruction companySpecification review and meetings regarding warehouse construction
2021EquipmentcGMPEquipment sales companyValidation training for equipment manufacturers (cGMP)
2021EquipmentGMPEquipment sales companyValidation training for equipment suppliers
2021EquipmentQMSEquipment sales companyValidation training for equipment manufacturers (QMS)
2021OthersCSVClinical laboratory testing companyCreation of a validation plan for the installation of a scratch system
2021OthersCSVClinical laboratory testing companyCSV consulting for installation of a scratch system
2021OthersCSVClinical laboratory testing companyCSV documentation support for installation of a scratch system
2021OthersCSVClinical laboratory testing companyCSV documentation support for the installation of a scratch system
2021OthersCSVClinical laboratory testing companyRisk assessment support for installation of a scratch system
2021OthersCSVClinical laboratory testing companyRisk assessment support for installation of a scratch system
2021OthersCSVClinical laboratory testing companyValidation report review for installation of a scratch system
2021OthersCSVClinical laboratory testing companyValidation report review for installation of a scratch system
2020PharmaceuticalcGMPAPI manufacturerFDA Mock inspection (cGMP)
2020PharmaceuticalcGMPAPI manufacturerReview of investigational drug records
2020PharmaceuticalcGMPAPI manufacturerTraining/Preparation for FDA Mock inspection (cGMP)
2020PharmaceuticalcGMPPharmaceutical MAHConstruction support of GMP document system (Investigational Drug GMP)
2020PharmaceuticalcGMPPharmaceutical MAHConstruction support of GMP organization (Investigational Drug GMP)
2020PharmaceuticalcGMPPharmaceutical MAHDI/ CSV training (Investigational Drug GMP)
2020PharmaceuticalcGMPPharmaceutical MAHGMP consulting for investigational drug manufacturer
2020PharmaceuticalcGMPPharmaceutical MAHGMP training (Investigational Drug GMP)
2020PharmaceuticalcGMPPharmaceutical MAHLecture SOP temprate (Investigational Drug GMP)
2020PharmaceuticalcGMPPharmaceutical MAHMaking SOP temprate (Investigational Drug GMP)
2020PharmaceuticalcGMPPharmaceutical MAHReview and Q&A SOP (Investigational Drug GMP)
2020PharmaceuticalcGMPPharmaceutical MAHReview of basic design for the construction of a pharmaceutical manufacturing facility (cGMP)
2020PharmaceuticalCSVAPI manufacturerCSV support for LIMS installation
2020PharmaceuticalGMPAPI manufacturerGMP consulting for a API manufacturer
2020PharmaceuticalGMPEvent companyCSV seminar for packaging equipment
2020PharmaceuticalGMPFoundationSeminar of FDF development for Japanese market
2020PharmaceuticalGMPPharmaceutical MAHProxy audit of Pharmaceutical Manufacturer (GMP)
2020PharmaceuticalGMPPharmaceutical MAHReview of GMP procedures for a pharmaceutical manufacturer
2020PharmaceuticalGMPTrading companyProxy audit of animal drug manufacturer (GMP)
2020PharmaceuticalGQPPharmaceutical MAHResearch for outsourcing contractor
2020PharmaceuticalInvestigational Drug GMPAPI manufacturerConfirmation for CAPA plan (Investigational Drug GMP)
2020PharmaceuticalInvestigational Drug GMPAPI manufacturerConfirmation for CAPA plan (Investigational Drug GMP)
2020PharmaceuticalInvestigational Drug GMPAPI manufacturerProxy audit of overseas investigational drug API manufacturer (Investigational Drug GMP)
2020PharmaceuticalInvestigational Drug GMPAPI manufacturerReview of CAPA plan (Investigational Drug GMP)
2020PharmaceuticalInvestigational Drug GMPPharmaceutical MAHGAP Analysis of investigational drug manufacturer (Investigational Drug GMP)
2020PharmaceuticalInvestigational Drug GMPWearhouse companyGMP audit of Pharmaceutical Manufacturer
2020PharmaceuticalPMD ActAPI manufacturerDMF consultation
2020PharmaceuticalPMD ActFoundationApplication support for Accredetation of Foreign Manufacturer
2020PharmaceuticalPMD ActFoundationApplication support for Accredetation of Foreign Manufacturer
2020PharmaceuticalPMD ActFoundationApplication support for Accredetation of Foreign Manufacturer
2020PharmaceuticalPMD ActFoundationRegulation consulting
2020PharmaceuticalPMD ActTrading companyRegulation consulting
2020PharmaceuticalPMD ActTrading companySupport of MF inquiry response from PMDA
2020Regenerative medicineGCTPEducational corporationConfirmation for consistency between documents and operation (GCTP)
2020Regenerative medicineGCTPEducational corporationCurrent situation analysis/consultation for regenarative medicine's factory (GCTP)
2020Regenerative medicineGCTPEducational corporationGCTP consulting
2020Regenerative medicineGCTPEducational corporationGMP/ GCTP training
2020Regenerative medicineGCTPEducational corporationMaking document system diagram for regenarative medicine's factory (GCTP)
2020Regenerative medicineGCTPEducational corporationMaking documents for regenarative medicine's factory (GCTP)
2020Regenerative medicineGCTPEducational corporationMaking SOPs for regenarative medicine's factory (GCTP)
2020Regenerative medicineGCTPEducational corporationMaking SOPs for regenarative medicine's factory (GCTP)
2020Regenerative medicineGCTPEducational corporationMaking SOPs for regenarative medicine's factory (GCTP)
2020Regenerative medicineGCTPEducational corporationReview documents for regenarative medicine's factory (GCTP)
2020Regenerative medicineGCTPEducational corporationTraining of GCTP/GxP for regenarative medicine's factory (GCTP)
2020Regenerative medicineGCTPRegenerative medicine MAHGAP analysis for a regenerative medicine manufacturer (GCTP)
2020Regenerative medicineGCTPRegenerative medicine MAHGCTP training
2020Regenerative medicineGCTPRegenerative medicine MAHReview for stabiity study report of regenerative medicine (GCTP)
2020Medical deviceCSVMedical device MAHCSV consulting for ERP system installation
2020Medical deviceCSVMedical device MAHCSV development documentation for ERP system installation
2020Medical deviceCSVMedical device MAHCSV support for ERP system installation (verification)
2020Medical deviceCSVMedical device MAHReview of CSV vendor's specifications (QMS)
2020Medical deviceQMSMedical device MAHSpecial adviser of medical devices company (QMS)
2020CosmeticcGMPCosmetic ingredient manufacuturerConstruction management (cGMP)
2020CosmeticcGMPCosmetic ingredient manufacuturerFDA Mock inspection of API Manufacturer (cGMP)
2020CosmeticcGMPCosmetic ingredient manufacuturerMaking basic engineering design and masterplan of factory construction (cGMP)
2020CosmeticcGMPCosmetic ingredient manufacuturerMaking detailed design of factory construction (cGMP)
2020CosmeticcGMPCosmetic ingredient manufacuturerQualification/Validation of factory construction (cGMP)
2020CosmeticcGMPCosmetic ingredient manufacuturerSelect for factory construction contractor/supplier of factory construction (cGMP)
2020CosmeticCosmetic GMPCosmetic manufacturerGAP Analysis of Cosmetics Manufacturer (Cosmetic GMP)
2020CosmeticEFfCICosmetic ingredient manufacuturerGAP Analysis of Cosmetic Ingredient Manufacturer (EFfCI GMP)
2020ConstructionGMPConstruction companySpecial adviser of construction company for getting construction project in pharmaceutical industry (GMP)
2020OthersCSVClinical laboratory testing companyCSV consulting for installation of a scratch system
2020OthersCSVClinical laboratory testing companyCSV documentation support for installation of a scratch system
2020OthersPMD ActCosmetic MAHResearch of claim/advertisement risk in Japan against medicated toothpasete from overseas country
2020OthersPMD ActCosmetic MAHResearch of how-to import medicated toothpasete in Japan from overseas country
2020OthersPMD ActCosmetic MAHResearch of how-to register as quasi-drug in Japan against medicated toothpaste from overseas country
2020OthersPMD ActCosmetic MAHResearch of regulation in Japan against medicated toothpaste from overseas country
2020OthersPMD ActQuasi-drug MAHConsultation for application of quasi-drug
2019PharmaceuticalcGMPAPI manufacturerAttend as an observer on inspection by authority
2019PharmaceuticalcGMPAPI manufacturercGMP consulting for API Manufacturer
2019PharmaceuticalcGMPAPI manufacturerFDA Mock inspection (cGMP)
2019PharmaceuticalcGMPAPI manufacturerGAP Analysis (cGMP)
2019PharmaceuticalcGMPAPI manufacturerGMP training (cGMP)
2019PharmaceuticalcGMPAPI manufacturerInstall PQS (cGMP)
2019PharmaceuticalcGMPAPI manufacturerMaking documents(cGMP)
2019PharmaceuticalcGMPAPI manufacturerReview of documents for application
2019PharmaceuticalcGMPAPI manufacturerReview of PV report (cGMP)
2019PharmaceuticalcGMPAPI manufacturerSupport for improvement (cGMP)
2019PharmaceuticalcGMPAPI manufacturerSupport qualification (cGMP)
2019PharmaceuticalcGMPAPI manufacturerSupport validation (cGMP)
2019PharmaceuticalcGMPPharmaceutical MAHCosultation of deviation SOP and record (GMP)
2019PharmaceuticalcGMPPharmaceutical MAHFDA inspection training (cGMP)
2019PharmaceuticalcGMPPharmaceutical MAHFDA Mock inspection (cGMP)
2019PharmaceuticalcGMPPharmaceutical MAHLecture of observations (cGMP)
2019PharmaceuticalcGMPPharmaceutical MAHSupport of CAPA (cGMP)
2019PharmaceuticalcGMPPharmaceutical MAHTraining of deviation (GMP)
2019PharmaceuticalGCPPharmaceutical MAHConsulting for FDF development (GCP)
2019PharmaceuticalGDPConsultantGDP seminar
2019PharmaceuticalGDPLogistics companyGAP Analysis (GDP)
2019PharmaceuticalGDPLogistics companyGDP training
2019PharmaceuticalGDPLogistics companyInvestigation for constructing GDP organization
2019PharmaceuticalGDPLogistics companyProxy audit of investigational drug storage contractors (GDP)
2019PharmaceuticalGMPAPI manufacturerAudit support (GMP)
2019PharmaceuticalGMPAPI manufacturerAudit support (GMP)
2019PharmaceuticalGMPAPI manufacturerCAPA training (GMP)
2019PharmaceuticalGMPAPI manufacturerChecking SOPs and records (GMP)
2019PharmaceuticalGMPAPI manufacturerConsulting of wholeseller's license (GMP)
2019PharmaceuticalGMPAPI manufacturerDiscussion how to get wholeseller's license (GMP)
2019PharmaceuticalGMPAPI manufacturerGAP Analysis of API Manufacturer (GMP)
2019PharmaceuticalGMPAPI manufacturerGMP consulting
2019PharmaceuticalGMPAPI manufacturerGMP consulting for API Manufacturer
2019PharmaceuticalGMPAPI manufacturerGMP consulting for API Manufacturer
2019PharmaceuticalGMPAPI manufacturerGMP consulting for API Manufacturer
2019PharmaceuticalGMPAPI manufacturerGMP improvement support for API Manufacturer
2019PharmaceuticalGMPAPI manufacturerGMP Ministerial Ordinance training
2019PharmaceuticalGMPAPI manufacturerGMP training
2019PharmaceuticalGMPAPI manufacturerGMP training
2019PharmaceuticalGMPAPI manufacturerGMP training of API Manufacturer
2019PharmaceuticalGMPAPI manufacturerInvestigation of GMP documents (GMP)
2019PharmaceuticalGMPAPI manufacturerMaking PQ protocol draft for HPAPI (GMP)
2019PharmaceuticalGMPAPI manufacturerProxy audit of API Manufacturer (GMP)
2019PharmaceuticalGMPAPI manufacturerProxy audit of API Manufacturer (GMP)
2019PharmaceuticalGMPAPI manufacturerReview of SOP (GMP)
2019PharmaceuticalGMPAPI manufacturerReview PQ protocol for HPAPI (GMP)
2019PharmaceuticalGMPAPI manufacturerSupprort for making SOP (GMP)
2019PharmaceuticalGMPAPI manufacturerTraining of wholeseller (GMP)
2019PharmaceuticalGMPFoundationTraining of practical QC (GMP)
2019PharmaceuticalGMPPharmaceutical MAHAttend as an observer on tech-transfer (GMP)
2019PharmaceuticalGMPPharmaceutical MAHConstruction support of GMP organization (GMP)
2019PharmaceuticalGMPPharmaceutical MAHConstruction support of GMP system (GMP)
2019PharmaceuticalGMPPharmaceutical MAHGAP Analysis of overseas pharmaceutical manufacturer (GMP)
2019PharmaceuticalGMPPharmaceutical MAHGMP consulting
2019PharmaceuticalGMPPharmaceutical MAHGMP training
2019PharmaceuticalGMPPharmaceutical MAHInvestigation of structure & equipments (GMP)
2019PharmaceuticalGMPPharmaceutical MAHMaking and Review of protocol for stability study
2019PharmaceuticalGMPPharmaceutical MAHMaking and Review of PV protocol (GMP)
2019PharmaceuticalGMPPharmaceutical MAHMaking and Review of PV report (GMP)
2019PharmaceuticalGMPPharmaceutical MAHPreparation for GMP compliance review by PMDA (GMP)
2019PharmaceuticalGMPPharmaceutical MAHRegulatory support
2019PharmaceuticalGMPPharmaceutical MAHReview and making support of protocol for tech-transfer (GMP)
2019PharmaceuticalGMPPharmaceutical MAHReview of applcation (GMP)
2019PharmaceuticalGMPPharmaceutical MAHReview of GQP Agreement (GMP)
2019PharmaceuticalGMPPharmaceutical MAHReview of Japanese PIF (GMP)
2019PharmaceuticalGMPPharmaceutical MAHReview of Japanese PIF (GMP)
2019PharmaceuticalGMPPharmaceutical MAHReview of MBR (GMP)
2019PharmaceuticalGMPPharmaceutical MAHReview of Plan & Report of PV (GMP)
2019PharmaceuticalGMPPharmaceutical MAHReview of Record & Report of PV (GMP)
2019PharmaceuticalGMPPharmaceutical MAHReview of specification and test method (GMP)
2019PharmaceuticalGMPPharmaceutical MAHReview of stability test result
2019PharmaceuticalGMPPharmaceutical MAHReview of tech-transfer (GMP)
2019PharmaceuticalGMPPharmaceutical MAHSelf-inspection of Pharmaceutical Manufacturer (GMP)
2019PharmaceuticalGMPPharmaceutical MAHSelf-inspection of Pharmaceutical Manufacturer (GMP)
2019PharmaceuticalGMPPharmaceutical MAHSupport fo GMP Compliance Reviews by PMDA
2019PharmaceuticalGMPPharmaceutical MAHTraining for operator (GMP)
2019PharmaceuticalGMPPharmaceutical MAHTraining of testing validation (GMP)
2019PharmaceuticalGMPPharmaceutical MAHTrend lecture of PMDA audit for overseas pharmaceutical manufacturer
2019PharmaceuticalGMPPharmaceutical MAHValidation training (GMP)
2019PharmaceuticalGMPQuasi-drug MAHGAP Analysis of overseas pharmaceutical manufacturer (GMP)
2019PharmaceuticalGMPTemporary staffing agencyGMP traiing
2019PharmaceuticalGMPTemporary staffing agencyGMP traiing
2019PharmaceuticalInvestigational Drug GMPAPI manufacturerProxy audit of overseas investigational drug API manufacturer (Investigational Drug GMP)
2019PharmaceuticalInvestigational Drug GMPLogistics companyReview of CAPA plan (Investigational Drug GMP)
2019PharmaceuticalInvestigational Drug GMPMedicine manufacturerProxy audit of investigational drug analysis contractor (Investigational Drug GMP)
2019PharmaceuticalInvestigational Drug GMPMedicine manufacturerProxy audit of investigational drug manufacturer (Investigational Drug GMP)
2019PharmaceuticalInvestigational Drug GMPMedicine manufacturerProxy audit of investigational drug manufacturer (Investigational Drug GMP)
2019PharmaceuticalInvestigational Drug GMPMedicine manufacturerReview of CAPA plan (Investigational Drug GMP)
2019PharmaceuticalOthersAPI manufacturerChecking requirement based on categorization HPAPI
2019PharmaceuticalOthersAPI manufacturerGAP Analysis of highly Pharmacologically Active API Manufacturer (GMP)
2019PharmaceuticalOthersAPI manufacturerReview of DMF Closed Part
2019PharmaceuticalOthersMedical device manufacturerProxy audit of a vial stopper manufacturer
2019PharmaceuticalPMD ActAPI manufacturerInvestigation of development documents
2019PharmaceuticalPMD ActPharmaceutical MAHApplication support for licence of pharmaceutical product manufacturer (GMP)
2019PharmaceuticalPMD ActPharmaceutical MAHConsultation of FDF development
2019PharmaceuticalPMD ActPharmaceutical MAHConsultation of transfer-approval
2019PharmaceuticalPMD ActTrading companyCoherent check between documents and operations (GMP)
2019PharmaceuticalPMD ActTrading companyMaking MF draft
2019PharmaceuticalPMD ActTrading companyMaking QOS draft
2019PharmaceuticalPMD ActTrading companyReview of documents for MF
2019PharmaceuticalPMD ActTrading companyTraining of Pharmaceutical regulation
2019Medical deviceCSVMedical device MAHCSV support for adding QMS management system modules (Project Management)
2019Medical deviceCSVMedical device MAHCSV support for module addition
2019Medical devicePMD ActMedical device MAHReview of application and attachements (QMS)
2019Medical devicePMD ActMedical device MAHSupport of PMDA's review (QMS)
2019Medical deviceQMSMedical device MAHConsultation of Q&A from notify body (ISO13485)
2019Medical deviceQMSMedical device MAHExamination support (ISO13485)
2019Medical deviceQMSMedical device MAHExamination support (ISO13485)
2019Medical deviceQMSMedical device MAHOutsourcing study support (ISO13485)
2019Medical deviceQMSMedical device MAHQMS support (QMS)
2019Medical deviceQMSMedical device MAHRisk management support (ISO13485)
2019Medical deviceQMSMedical device MAHSelf-inspection support (ISO13485)
2019Medical deviceQMSMedical device MAHStability study support (QMS)
2019Medical deviceQMSMedical device manufacturerConsultion of medical devices development
2019Medical deviceQMSMedical device manufacturerDI training (QMS)
2019Medical deviceQMSMedical device manufacturerFeasibility study for getting license (QMS)
2019Medical deviceQMSMedical device manufacturerFeasibilty study in each regions (ISO13485)
2019Medical deviceQMSMedical device manufacturerGAP Analysis of medical device manufacturer (ISO13485 and regulations)
2019Medical deviceQMSMedical device manufacturerGAP Analysis of medical device manufacturer (QMS)
2019Medical deviceQMSMedical device manufacturerGAP Analysis of medical device manufacturer (QMS)
2019Medical deviceQMSMedical device manufacturerGAP Analysis of medical device manufacturer (QMS)
2019Medical deviceQMSMedical device manufacturerLecture of each relulations in the regions (ISO13485)
2019Medical deviceQMSMedical device manufacturerMedical devices consultation
2019Medical deviceQMSMedical device manufacturerSupport feasibility study in medical decices industry
2019Medical deviceQMSMedical device manufacturerSupport of instal QMS (ISO9001/13485)
2019Medical deviceQSRMedical device MAHConstruction support of GMP organization (QMS)
2019Medical deviceQSRMedical device MAHConsultation for making answer against observation (QMS)
2019Medical deviceQSRMedical device MAHConsultation for re-examination (QMS)
2019Medical deviceQSRMedical device MAHGAP Analysis of medical device manufacturer (QSR)
2019Medical deviceQSRMedical device MAHMedical devices training
2019Medical deviceQSRMedical device MAHReview and making support of documents (QMS)
2019Medical deviceQSRMedical device MAHSupprort for making documents (QMS)
2019Medical deviceQSRMedical device manufacturerGAP Analysis of medical device manufacturer (QSR)
2019Medical deviceQSRMedical device manufacturerInvestigation of structure & equipments
2019Medical deviceQSRMedical device manufacturerMaking renewal consept design of structure & equipments
2019Medical deviceQSRMedical device manufacturerQSR & sterilization training (QSR)
2019Medical deviceQSRMedical device manufacturerSupport for factory renovation (QSR)
2019Medical deviceQSRMedical device manufacturerSupport for making document system based on QSR & ISO13485
2019Medical deviceQSRMedical device manufacturerSupprot for factory validation
2019CosmeticcGMPCosmetic ingredient manufacuturerBasic plan/design work support for new factory (cGMP)
2019CosmeticcGMPCosmetic ingredient manufacuturercGMP training
2019CosmeticcGMPCosmetic ingredient manufacuturercGMP training
2019CosmeticcGMPCosmetic ingredient manufacuturerReview of Form 483 (cGMP)
2019CosmeticcGMPCosmetic ingredient manufacuturerSupport of making URS for new factory (cGMP)
2019CosmeticcGMPCosmetic ingredient manufacuturerValidation support for new factory (cGMP)
2019CosmeticCosmetic GMPCosmetic ingredient manufacuturerConsulting for development of cosmetic ingredient (Cosmetic GMP)
2019CosmeticCosmetic GMPCosmetic MAHCosmetic GMP training
2019CosmeticCosmetic GMPCosmetic MAHGAP Analysis (CosmeticGMP)
2019CosmeticCosmetic GMPCosmetic MAHMock Inspection of Cosmetics Manufacturer (Cosmetic GMP)
2019CosmeticCosmetic GMPCosmetic MAHSupport for SOP modification (Cosmetic GMP)
2019CosmeticCosmetic GMPCosmetic manufacturerGAP Analysis of Cosmetics Manufacturer (Cosmetic GMP)
2019CosmeticCSVCosmetic ingredient manufacuturerCSV support for new factory (cGMP)
2019CosmeticEFfCICosmetic ingredient manufacuturerConstruction support of GMP organization(EFfCI GMP)
2019CosmeticEFfCICosmetic ingredient manufacuturerGAP Analysis of Cosmetic Ingredient Manufacturer (EFfCI GMP)
2019CosmeticEFfCICosmetic ingredient manufacuturerInvestigation of drawing and equimment (EFfCI GMP)
2019CosmeticEFfCICosmetic ingredient manufacuturerLecture SOP temprate (EFfCI GMP)
2019CosmeticEFfCICosmetic ingredient manufacuturerMaking template of SOPs (EFfCI GMP)
2019CosmeticEFfCICosmetic ingredient manufacuturerReview of SOP (EFfCI GMP)
2019CosmeticEFfCICosmetic ingredient manufacuturerSupport for making document system (EFfCI GMP)
2019CosmeticEFfCICosmetic ingredient manufacuturerTraining and Q&A of GMP (EFfCI GMP)
2019MaterialQMSMedical device manufacturerBasic training of Medical Devices (QMS)
2019MaterialQMSMedical device manufacturerConsulting way of sterilization, and suitable equipment (QMS)
2019MaterialQMSMedical device manufacturerFeasibility study support (QMS)
2019MaterialQMSMedical device manufacturerFeasibility study support of layout (QMS)
2019MaterialQMSMedical device manufacturerSupport for estimation of cost (QMS)
2019MaterialQMSMedical device manufacturerSupport of line layout (QMS)
2019ConstructioncGMPConstruction companycGMP training
2019ConstructionCosmetic GMPConstruction companyBasic plan support (ISO22716)
2019ConstructionGMPConstruction companyCompetition support as an inner consultant (GMP)
2019EquipmentGMPEquipment sales companyConsultation for development of medical devices
2019OthersCSVClinical laboratory testing companyCSV consulting for installation of a scratch system
2019OthersCSVClinical laboratory testing companyReview of CSV documentation in the installation of a scratch system
2019OthersGMPAnalysis companyGAP Analysis of analysis contractor (GMP)
2019OthersGMPAnalysis companyGMP consulting
2019OthersGMPConsultantGMP seminar
2019OthersGMPConsultantGMP seminar
2019OthersGMPEvent companyDI seminar
2019OthersOthersEvent companyAPI Supply Chain Management seminar (GQP)
2019OthersPMD ActConsultantInvestigation of Quasi-drugs regulation
2019OthersQMSFoundationAutomatic recognition system seminar (QMS)
2018PharmaceuticalcGMPAPI manufacturercGMP consulting
2018PharmaceuticalcGMPAPI manufacturerGAP Analysis of API Manufacturer (cGMP)
2018PharmaceuticalcGMPAPI manufacturerMock Inspection of API manufacturer (DI)
2018PharmaceuticalcGMPAPI manufacturerReview of PV plan (cGMP)
2018PharmaceuticalEXCiPACTAPI manufacturerGAP Analysis of pharmaceutical excipients manufacturer (EXCiPACT)
2018PharmaceuticalGCPPharmaceutical MAHCorrection support of SOP (GCP)
2018PharmaceuticalGCPPharmaceutical MAHGCP training
2018PharmaceuticalGCPPharmaceutical MAHMaking SOP temprate (GCP)
2018PharmaceuticalGDPCertification bodySeminar of GDP
2018PharmaceuticalGMPAPI manufacturerGAP Analysis of API manufacturers (DI)
2018PharmaceuticalGMPAPI manufacturerGAP analysis of overseas API manufacture (GMP)
2018PharmaceuticalGMPAPI manufacturerGMP auditor training
2018PharmaceuticalGMPAPI manufacturerGMP document maintenance and document system reconstruction support
2018PharmaceuticalGMPAPI manufacturerGMP training
2018PharmaceuticalGMPAPI manufacturerLecture SOP temprate (GMP), and discussion plan
2018PharmaceuticalGMPAPI manufacturerLecture SOP temprate (GMP), and discussion plan
2018PharmaceuticalGMPAPI manufacturerMaking SOP temprate (GMP)
2018PharmaceuticalGMPAPI manufacturerMaking SOP temprate (GMP)
2018PharmaceuticalGMPAPI manufacturerReview and Q&A SOP (GMP)
2018PharmaceuticalGMPAPI manufacturerReview and Q&A SOP (GMP)
2018PharmaceuticalGMPAPI manufacturerReview of basic design (GMP)
2018PharmaceuticalGMPConsultantSeminar of PMD Act & GMP
2018PharmaceuticalGMPFoundationGMP training (basic QC)
2018PharmaceuticalGMPFoundationGMP training (practical QC)
2018PharmaceuticalGMPPharmaceutical MAHDI consultation
2018PharmaceuticalGMPPharmaceutical MAHDI training
2018PharmaceuticalGMPPharmaceutical MAHGMP training
2018PharmaceuticalGMPPharmaceutical MAHGMP training (Self-inspection)
2018PharmaceuticalGMPPharmaceutical MAHGMP training (supplier audit)
2018PharmaceuticalGMPPharmaceutical MAHOperation verification support based on PMS
2018PharmaceuticalGMPPharmaceutical MAHOperation verification support based on PMS
2018PharmaceuticalGMPPharmaceutical MAHOperation verification support based on PQS
2018PharmaceuticalGMPPharmaceutical MAHOperation verification support based on PQS
2018PharmaceuticalGMPPharmaceutical MAHOperation verification support based on PQS
2018PharmaceuticalGMPPharmaceutical MAHProxy audit of API manufacturer (GMP)
2018PharmaceuticalGMPPharmaceutical MAHProxy audit of API Manufacturer (GMP)
2018PharmaceuticalGMPPrinting companySeminar of QA for new drug development
2018PharmaceuticalGMPTrading companyGAP Analysis of pharmaceutical manufacture (packaging, labeling, storage) (GMP)
2018PharmaceuticalGMPTrading companyMaking GMP documents and operation support
2018PharmaceuticalGMPTrading companyTraining of SOP (GMP)
2018PharmaceuticalGQPPharmaceutical MAHCoherent check between documents and operations(API)
2018PharmaceuticalGQPPharmaceutical MAHCoherent check between documents and operations(FDF)
2018PharmaceuticalGQPPharmaceutical MAHCoherent check between SOPs (GMP)
2018PharmaceuticalGQPPharmaceutical MAHSupport for revision of internal QA regulations
2018PharmaceuticalInvestigational Drug GMPAPI manufacturerProxy audit of investigational API manufacturer (Investigational Drug GMP)
2018PharmaceuticalInvestigational Drug GMPAPI manufacturerProxy audit of investigational API manufacturer (Investigational Drug GMP)
2018PharmaceuticalInvestigational Drug GMPMedicine manufacturerProxy audit of investigational drug packaging contractor (Investigational Drug GMP)
2018PharmaceuticalInvestigational Drug GMPWearhouse companyProxy audit of investigational API manufacturer (Investigational Drug GMP)
2018PharmaceuticalKGMPPharmaceutical MAHGAP Analysis of Pharmaceutical Manufacturer (KGMP)
2018PharmaceuticalPMD ActPharmaceutical MAHConsultation of development and regulation
2018PharmaceuticalPMD ActPharmaceutical MAHDMF consultation
2018PharmaceuticalPMD ActPharmaceutical MAHRegulation consulting
2018PharmaceuticalPMD ActPharmaceutical MAHResearch for development and regulation
2018Medical deviceCSVMedical device MAHCSV support for adding QMS management system modules (Project Management)
2018Medical deviceCSVMedical device manufacturerER/ES support for core systems
2018Medical deviceGMPMedical device manufacturerTraining GMP and engineering
2018Medical deviceQMSMedical device MAHAttend as an observer on PQ
2018Medical deviceQMSMedical device MAHAttend as an observer on PV
2018Medical deviceQMSMedical device MAHConsultation Medical devices business
2018Medical deviceQMSMedical device MAHConsultation of Pharmacetuticals/Meical devices business
2018Medical deviceQMSMedical device MAHMaking SOP support based on ER/ES
2018Medical deviceQMSMedical device MAHMaking support of Valdation plan
2018Medical deviceQMSMedical device MAHReview for validation plan (DQ・IQ・OQ・PQ)
2018Medical deviceQMSMedical device MAHReview for validation report (DQ・IQ・OQ・PQ)
2018Medical deviceQMSMedical device MAHReview of Validation record
2018Medical deviceQMSMedical device MAHSupport for selection of vendor/specification
2018Medical deviceQSRMedical device MAHReview and making support of documents (CSV)
2018CosmeticcGMPCosmetic ingredient manufacuturercGMP training
2018CosmeticcGMPCosmetic ingredient manufacuturerDesign review and meeting for new factory construction
2018CosmeticcGMPCosmetic ingredient manufacuturerReview of validation documents for new factory construction
2018CosmeticCosmetic GMPCosmetic manufacturerGAP Analysis of Cosmetics Manufacturer (Cosmetic GMP)
2018CosmeticCosmetic GMPCosmetic manufacturerGAP Analysis of cosmetics manufacturers (ISO22716)
2018CosmeticCSVCosmetic ingredient manufacuturerCSV support for DCS installation (Draft of development plan)
2018CosmeticCSVCosmetic ingredient manufacuturerDQ evaluation support for DCS installation
2018CosmeticCSVCosmetic ingredient manufacuturerFS preparation support for DCS installation
2018CosmeticCSVCosmetic ingredient manufacuturerIQ documentation and evaluation support for DCS installation
2018CosmeticCSVCosmetic ingredient manufacuturerOQ documentation and evaluation support for DCS installation
2018CosmeticCSVCosmetic ingredient manufacuturerPQ document preparation and evaluation support for DCS installation
2018CosmeticCSVCosmetic ingredient manufacuturerSupport for DS document preparation for DCS installation
2018CosmeticCSVCosmetic ingredient manufacuturerSupport for preparation of validation plan for DCS installations
2018CosmeticCSVCosmetic ingredient manufacuturerURS preparation support for DCS installation
2018CosmeticCSVCosmetic ingredient manufacuturerValidation report writing for DCS installation
2018CosmeticEFfCICosmetic ingredient manufacuturerEFfCI GMP training
2018CosmeticEFfCICosmetic ingredient manufacuturerGAP Analysis of Cosmetic Ingredient Manufacturer (EFfCI GMP)
2018CosmeticEFfCISupplement ingredient manufacturerInvestigation of SOPs (EFfCI)
2018CosmeticEXCiPACTCosmetic ingredient manufacuturerGAP Analysis of pharmaceutical excipients manufacturer (EXCiPACT)
2018CosmeticGCPCosmetic ingredient manufacuturerProxy audit of overseas testing outsourcing partners (GCP)
2018OthersCSVClinical laboratory testing companyPQ support for QMS management system installation
2018OthersCSVClinical laboratory testing companyReview of vendor documentation for QMS management system installation
2018OthersCSVClinical laboratory testing companySupport for preparation of project reports for QMS management system installation
2018OthersCSVClinical laboratory testing companySupport for preparation of validation plans for QMS management system installations
2018OthersCSVClinical laboratory testing companySystem training for QMS management system installation
2018OthersCSVClinical laboratory testing companyURS creation support for QMS management system installation
2018OthersGMPConsultantGMP seminar
2018OthersGMPTemporary staffing agencyAttend as an observer on GMP seminar

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