Our Performance

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The ratio of our performance in industry (2018 - 2023 June)

The ratio of our performance in Service (2018 - 2023 June)

The ratio of our performance in Regulation (2018 - 2023 June)

Performance list (2018 - 2023 June)

MAH : Marketing authorization holder
API : Active Pharmaceutical Ingredient
CSV:Computerized system validation

 

 
Consulting year Domestic or overseas Regulation Category of company Kind of service
2023 Domestic cGMP API manufacturer Training for cGMP
2023 Domestic Others Pharmaceutical MAH Consultation for pharmaceutical business
2023 Domestic GMP API manufacturer Training for self-inspection
2023 Domestic GMP API manufacturer On-the-job training for self-inspection
2023 Domestic GMP Pharmaceutical MAH Review of CTD
2023 Domestic PMD Act Pharmaceutical MAH Consultation and evaluation of PTP sheets
2023 Domestic Investigational Drug GMP Medicine manufacturer Consultation on investigational drug stability testing
2023 Domestic GVP Pharmaceutical MAH Sales of GVP procedures
2023 Domestic GMP API manufacturer Audit for Quality Management System for API manufacturer
2023 Domestic GMP Medicine manufacturer GAP analysis for pharmaceutical manufacturer (GMP)
2023 Domestic GMP Medicine manufacturer Research support for Reconstruction of pharmaceutical production area
2023 Domestic PMD Act Pharmaceutical MAH Consultation on product labels for pharmaceutical Drug Product
2023 Domestic GMP Medicine manufacturer Review of basic and detailed design documents for the construction of pharmaceutical manufacturing plant
2023 Domestic GMP Medicine manufacturer Support for preparation of architectural URS and VMP for pharmaceutical manufacturing plant
2023 Domestic GMP Medicine manufacturer Support for DQ plan preparation of pharmaceutical manufacturing plant
2023 Domestic GMP Medicine manufacturer FAT surpport for preparation of pharmaceutical manufacturing plant
2023 Domestic GMP Medicine manufacturer Support for IOQ plan review of pharmaceutical manufacturing plant
2023 Domestic CSV Medicine manufacturer Training for CSV guidelines
2023 Domestic GMP Medicine manufacturer Training for aseptic formulation(PIC/S ANEEX1)
2023 Domestic GMP Medicine manufacturer Training for DI
2023 Domestic GMP Medicine manufacturer Training for compliance in pharmaceutical manufacturing
2023 Domestic GMP Medicine manufacturer Training for technology transfer
2023 Domestic GMP Pharmaceutical MAH Evaluation of manufacturing line drawings for high pharmacological formulation
2023 Domestic cGMP Medicine manufacturer Mock audit of investigational drug manufacturing plant (injectable drug)
2023 Domestic GMP API manufacturer GMP consulting for API manufacturer
2023 Domestic Investigational Drug GMP Medicine manufacturer Consultation on manufacturing of APIs for clinical trials
2023 Domestic GMP Pharmaceutical MAH GAP Analysis of Pharmaceutical Manufacturer
2023 Domestic GMP Pharmaceutical MAH Consultation on contract manufacturing management
2023 Overseas GMP Medicine manufacturer Proxy audits for overseas manufacturer (GMP)
2023 Domestic GMP Medicine manufacturer Support for survey of current conditions for vector production
2023 Domestic GMP Medicine manufacturer Proxy audits for Pharmaceutical manufacturer (Investigational Drug GMP)
2023 Domestic GMP Pharmaceutical MAH Support for creating procedures related to manufacturing equipment
2023 Domestic GMP Pharmaceutical MAH Support for revision of master batch records
2023 Domestic GMP Pharmaceutical MAH GMP document inspection
2023 Domestic GMP Pharmaceutical MAH GMP document Revision
2023 Domestic GMP Pharmaceutical MAH Review of validation documents
2023 Domestic CSV Medicine manufacturer CSV Training
2023 Overseas GMP API manufacturer Proxy audits for overseas API manufacturer (GMP)
2023 Overseas GMP API manufacturer Proxy audits for overseas API manufacturer (GMP)
2023 Overseas GMP API manufacturer Proxy audits for overseas API manufacturer (GMP)
2023 Overseas GMP API manufacturer Proxy audits for overseas API manufacturer (GMP)
2023 Overseas GMP API manufacturer Proxy audits for overseas API manufacturer (GMP)
2023 Domestic GMP System company GMP Seminar
2023 Domestic GMP Medicine manufacturer Support for review of procedures related to DI
2023 Domestic GMP Medicine manufacturer Support for review of procedures related to education and training
2022 Domestic CSV Pharmaceutical MAH Support for review of validation plan for scratch system implementation
2022 Domestic CSV Pharmaceutical MAH URS review support for scratch system implementation
2022 Domestic GMP Pharmaceutical MAH Support on supplier audits of scratch system implementation
2022 Domestic CSV Pharmaceutical MAH Support for DQ review of scratch system implementation
2022 Domestic CSV Pharmaceutical MAH Support for IQ review scratch system implementation
2022 Domestic CSV Pharmaceutical MAH Support for OQ review scratch system implementation
2022 Domestic Others Medicine manufacturer Serialization Overview Training
2022 Domestic PMD Act Pharmaceutical MAH Consultation for tablet imprinting
2022 Domestic Others Pharmaceutical MAH Consultation for contamination with foreign materials
2022 Domestic cGMP Medicine manufacturer Support for evaluation of cGMP compliance for export of investigational API to the U.S.
2022 Domestic GMP Trading company Training of management on pharmaceutical quality systems
2022 Domestic Investigational Drug GMP Medicine manufacturer Development support in investigational drug manufacturing
2022 Domestic GMP Pharmaceutical MAH Training about MF
2022 Domestic PMD Act Pharmaceutical MAH Making MF draft
2022 Domestic CSV Medicine manufacturer Creation of Validation Master Plan
2022 Domestic CSV Medicine manufacturer Creation of URS
2022 Domestic CSV Medicine manufacturer DQ surpport
2022 Domestic CSV Medicine manufacturer FAT surpport
2022 Domestic CSV Medicine manufacturer IQ/OQ surpport
2022 Domestic CSV Medicine manufacturer CSV report preparation
2022 Domestic Investigational Drug GMP Medicine manufacturer Proxy audit of investigational drug manufacturer (Investigational Drug GMP)
2022 Domestic GMP Medicine manufacturer Consultation for Reference Standard
2022 Overseas GMP Medicine manufacturer PMDA Mock Inspection of Overseas Biological Drug Manufacturing Sites
2022 Overseas GMP Medicine manufacturer Proxy audits of API Manufacturer (GMP)
2022 Domestic CSV System company CSV training for system vendors
2022 Overseas GMP Trading company Proxy audits for overseas API manufacturer (GMP)
2022 Domestic GMP Medicine manufacturer Support for preparation of tertiary documents related for GMP
2022 Domestic GMP Medicine manufacturer Support for revalidation of relocated equipments
2022 Domestic GMP Medicine manufacturer Instruction on equipment calibration and periodic inspections
2022 Domestic GMP Medicine manufacturer Creation of Validation Master Plan
2022 Domestic GMP Medicine manufacturer Support for environmental validation documentation and execution
2022 Domestic GMP Medicine manufacturer Support for temperature mapping documentation and execution
2022 Domestic GMP Medicine manufacturer Support for sterilization validation documentation and execution
2022 Domestic GMP Medicine manufacturer Support for PQ documentation and execution of equipment and facilities
2022 Domestic GMP Medicine manufacturer Support forGrowth Promotion Test documentation and execution
2022 Domestic GMP Medicine manufacturer Support the creation of Transport Verification documentationand execution
2022 Domestic PMD Act Medical device MAH Evaluation of Elemental Impurities
2022 Domestic GMP API manufacturer Support for establishment of pharmaceutical quality system
2022 Domestic GMP API manufacturer Support for cleaning validation of common equipment
2022 Domestic GMP API manufacturer GMP training
2022 Domestic CSV API manufacturer Advice for warehouse management system installation
2022 Domestic GMP API manufacturer GMP Consulting
2022 Domestic GMP Pharmaceutical MAH Proxy audits of pharmaceutical manufacture (GMP)
2022 Domestic GMP Medicine manufacturer GAP analysis of GMP procedures
2022 Domestic CSV Pharmaceutical MAH URS Review for Scratch System Installation
2022 Domestic GMP Medicine manufacturer GMP training
2022 Domestic GMP Medicine manufacturer CAPA Plan Review of GAP Analysis Findings
2022 Domestic cGMP Medicine manufacturer GAP analysis for laboratories (cGMP)
2022 Overseas GMP Pharmaceutical MAH Interpretation for PMDA remote inspections of overseas API manufacturer
2022 Overseas GMP APIs intermediates manufacturer GMP consulting for API intermediate manufacturer
2022 Domestic PMD Act Regenerative medicine MAH Support for evaluation of elemental impurities (ICH Q3D)
2022 Domestic GMP Medicine manufacturer Proxy for paper audit of overseas API manufacturer (GMP)
2022 Overseas GMP Pharmaceutical MAH Interpretation for PMDA remote inspections of overseas API manufacturing sites
2022 Domestic CSV Pharmaceutical MAH Review of system specifications for installation of a scratch system
2022 Domestic GMP API manufacturer GAP analysis of API manufacturer (GMP)
2022 Domestic Investigational Drug GMP Medicine manufacturer GAP Analysis (Investigational Drug GMP)
2022 Domestic GMP Medical device MAH Organizing requirements for pharmaceutical manufacturing applications (GCTP)
2022 Domestic GMP Medical device MAH Organize requirements for setting up a GMP manufacturing facility
2022 Domestic GMP Medicine manufacturer Interpretation support for pharmaceutical-related business
2022 Domestic GMP Medicine manufacturer Support for SOP restructuring study (GMP)
2022 Domestic GMP Medicine manufacturer GAP analysis of pharmaceutical Manufacturer (EU GMP)
2022 Domestic PMD Act Trading company Investigation to set specifications
2022 Domestic GMP Medicine manufacturer Proxy for paper audit (GMP)
2022 Domestic GMP Trading company GMP Training for Management
2022 Domestic Others API manufacturer Support for registration with the U.S. DMF
2021 Domestic GMP Trading company Selling SOPs
2021 Domestic GDP Certification body Seminar of GDP
2021 Overseas GMP Medicine manufacturer Consultation for Validation of Packaging
2021 Domestic GMP Pharmaceutical MAH Support for preparation of formats for paper-based GMP audits
2021 Domestic cGMP API manufacturer cGMP consulting
2021 Domestic CSV Medicine manufacturer Consulting for system implementation
2021 Domestic GMP Pharmaceutical MAH Proxy audit of Pharmaceutical Manufacturer (GMP)
2021 Domestic GMP Medicine manufacturer GMP training
2021 Domestic QMS Event company CSA seminar
2021 Domestic GMP Trading company Support for preparation of formats for paper-based GMP audits
2021 Overseas PMD Act Foundation Application support for Accredetation of Foreign Manufacturer
2021 Domestic GMP Medicine manufacturer GAP Analysis of Pharmaceutical Manufacturer (GMP)
2021 Domestic GMP Medicine manufacturer GAP Analysis of Pharmaceutical Manufacturer (GMP)
2021 Overseas PMD Act Pharmaceutical MAH Consultation for Stability Testing
2021 Overseas PMD Act Pharmaceutical MAH Consultation for change of Critical Control Parameter
2021 Domestic GMP Reagent Manufacturing and Sales Company Review of analytical procedure validation protocols (GMP)
2021 Domestic GMP Medicine manufacturer Proxy audits of API Manufacturer (GMP)
2021 Domestic GMP Pharmaceutical MAH Proxy audits for pharmaceutical manufacturer (GMP)
2021 Overseas Investigational Drug GMP Pharmaceutical MAH Confirmation for CAPA plan (Investigational Drug GMP)
2021 Domestic GMP Pharmaceutical MAH Confirmation of the current status of the PQS at the injectable manufacturing plant(GMP)
2021 Domestic GMP API manufacturer Proxy audits of starting material manufacturing facilities
2021 Overseas GMP Medicine manufacturer Review of layout design (GMP)
2021 Overseas GMP Foundation J-GMP Seminar for Overseas Pharmaceutical Manufacturers
2021 Domestic cGMP Pharmaceutical MAH cGMP consulting for API manufacturer
2021 Domestic GMP Medicine manufacturer Consultation of microbial control (GMP)
2021 Overseas GMP Medicine manufacturer Feasibility study support for the construction of an injection drug manufacturing plant
2021 Overseas GMP Medicine manufacturer Conceptual design support for construction of an injectable drug manufacturing plant
2021 Overseas GMP Medicine manufacturer Basic design support for the construction of an injectable drug manufacturing plant
2021 Overseas GMP Medicine manufacturer Detailed design support for the construction of an injectable drug manufacturing plant
2021 Domestic GMP Trading company Training of GMP audit
2021 Domestic GMP Medicine manufacturer Proxy audits for pharmaceutical manufacturer (GMP)
2021 Domestic GMP Medicine manufacturer Proxy audits for pharmaceutical manufacturer (GMP)
2021 Domestic GMP Medicine manufacturer Evaluation of microbial control (GMP)
2021 Domestic GMP API manufacturer Confirmation for CAPA plan (GMP)
2021 Overseas Investigational Drug GMP API manufacturer Confirmation for CAPA plan (Investigational Drug GMP)
2021 Domestic GMP Medicine manufacturer GMP training
2021 Domestic GMP Medicine manufacturer Review of SOP (GMP)
2021 Domestic CSV Medicine manufacturer CSV consulting (GMP)
2021 Domestic GMP Medicine manufacturer Support for improving manufacturing records (GMP)
2021 Domestic GMP Pharmaceutical MAH GAP analysis for pharmaceutical manufacturer (GMP)
2021 Domestic GMP Pharmaceutical MAH GAP analysis for pharmaceutical manufacturer (GMP)
2021 Domestic GMP API manufacturer GMP consulting for API manufacturer
2021 Overseas GMP Medicine manufacturer Conceptual design review for the construction of a pre-filled syringe manufacturing line
2021 Overseas GMP Medicine manufacturer Review of basic design for pre-filled syringe manufacturing line installation
2021 Overseas GMP Medicine manufacturer Detailed design review of pre-filled syringe manufacturing line installation
2021 Domestic cGMP Medicine manufacturer GAP analysis for pharmaceutical manufacturer (cGMP)
2021 Domestic Investigational Drug GMP Drug discovery company Investigational Drug GMP consulting
2020 Overseas PMD Act Foundation Application support for Accredetation of Foreign Manufacturer
2020 Domestic cGMP Pharmaceutical MAH Review of basic design for the construction of a pharmaceutical manufacturing facility (cGMP)
2021 Domestic Investigational Drug GMP Drug discovery company Investigational Drug GMP consulting
2021 Overseas Investigational Drug GMP Medicine manufacturer Proxy audits for overseas investigational drug manufacturer (Investigational Drug GMP)
2021 Domestic Investigational Drug GMP Drug discovery company Review of SOP (GMP)
2020 Overseas PMD Act API manufacturer DMF consultation
2020 Domestic PMD Act Trading company Regulation consulting
2021 Domestic GQP Trading company GQP consulting
2020 Domestic GMP Event company CSV seminar for packaging equipment
2020 Overseas PMD Act Foundation Regulation consulting
2020 Overseas Investigational Drug GMP API manufacturer Confirmation for CAPA plan (Investigational Drug GMP)
2020 Domestic cGMP Pharmaceutical MAH Construction support of GMP organization (Investigational Drug GMP)
2020 Domestic cGMP Pharmaceutical MAH Construction support of GMP document system (Investigational Drug GMP)
2020 Domestic cGMP Pharmaceutical MAH Making SOP temprate (Investigational Drug GMP)
2020 Domestic cGMP Pharmaceutical MAH Lecture SOP temprate (Investigational Drug GMP)
2020 Domestic cGMP Pharmaceutical MAH Review and Q&A SOP (Investigational Drug GMP)
2020 Domestic cGMP Pharmaceutical MAH GMP training (Investigational Drug GMP)
2020 Domestic cGMP Pharmaceutical MAH DI/ CSV training (Investigational Drug GMP)
2020 Domestic cGMP API manufacturer Review of investigational drug records
2020 Domestic cGMP Pharmaceutical MAH GMP consulting for investigational drug manufacturer
2020 Domestic GMP API manufacturer GMP consulting for a API manufacturer
2020 Domestic GMP Pharmaceutical MAH Review of GMP procedures for a pharmaceutical manufacturer
2020 Overseas Investigational Drug GMP API manufacturer Confirmation for CAPA plan (Investigational Drug GMP)
2020 Overseas Investigational Drug GMP API manufacturer Review of CAPA plan (Investigational Drug GMP)
2020 Overseas PMD Act Foundation Application support for Accredetation of Foreign Manufacturer
2020 Domestic Investigational Drug GMP Pharmaceutical MAH GAP Analysis of investigational drug manufacturer (Investigational Drug GMP)
2020 Domestic GMP Trading company Proxy audit of animal drug manufacturer (GMP)
2020 Domestic GMP Pharmaceutical MAH Proxy audit of Pharmaceutical Manufacturer (GMP)
2020 Domestic PMD Act Trading company Support of MF inquiry response from PMDA
2020 Overseas GMP Foundation Seminar of FDF development for Japanese market
2020 Domestic Investigational Drug GMP Wearhouse company GMP audit of Pharmaceutical Manufacturer
2020 Overseas Investigational Drug GMP API manufacturer Proxy audit of overseas investigational drug API manufacturer (Investigational Drug GMP)
2020 Overseas PMD Act Foundation Application support for Accredetation of Foreign Manufacturer
2020 Domestic GQP Pharmaceutical MAH Research for outsourcing contractor
2020 Domestic cGMP API manufacturer Training/Preparation for FDA Mock inspection (cGMP)
2020 Domestic cGMP API manufacturer FDA Mock inspection (cGMP)
2020 Domestic CSV API manufacturer CSV support for LIMS installation
2019 Domestic GCP Pharmaceutical MAH Consulting for FDF development (GCP)
2019 Domestic GMP API manufacturer GMP training
2019 Domestic GMP API manufacturer GMP consulting
2019 Domestic cGMP Pharmaceutical MAH FDA inspection training (cGMP)
2019 Domestic cGMP Pharmaceutical MAH FDA Mock inspection (cGMP)
2019 Domestic cGMP Pharmaceutical MAH Lecture of observations (cGMP)
2019 Domestic cGMP Pharmaceutical MAH Support of CAPA (cGMP)
2019 Domestic PMD Act Trading company Review of documents for MF
2019 Domestic PMD Act Trading company Making MF draft
2019 Domestic PMD Act Trading company Making QOS draft
2019 Domestic PMD Act Trading company Coherent check between documents and operations (GMP)
2019 Domestic GMP API manufacturer Making PQ protocol draft for HPAPI (GMP)
2019 Domestic GMP API manufacturer Review PQ protocol for HPAPI (GMP)
2019 Domestic GMP API manufacturer Discussion how to get wholeseller's license (GMP)
2019 Domestic GMP API manufacturer Training of wholeseller (GMP)
2019 Domestic GMP API manufacturer Supprort for making SOP (GMP)
2019 Domestic GMP API manufacturer Consulting of wholeseller's license (GMP)
2019 Domestic GMP Pharmaceutical MAH Review of Record & Report of PV (GMP)
2019 Domestic GMP Pharmaceutical MAH GMP consulting
2019 Domestic GMP Pharmaceutical MAH Validation training (GMP)
2019 Domestic GMP Pharmaceutical MAH Investigation of structure & equipments (GMP)
2019 Domestic GMP Pharmaceutical MAH Review of Plan & Report of PV (GMP)
2019 Domestic Others Medical device manufacturer Proxy audit of a vial stopper manufacturer
2019 Domestic GDP Consultant GDP seminar
2019 Overseas PMD Act Pharmaceutical MAH Consultation of FDF development
2019 Domestic GMP API manufacturer Audit support (GMP)
2019 Domestic GMP API manufacturer Audit support (GMP)
2019 Domestic cGMP API manufacturer GMP training (cGMP)
2019 Domestic cGMP API manufacturer Support for improvement (cGMP)
2019 Domestic cGMP API manufacturer Install PQS (cGMP)
2019 Domestic cGMP API manufacturer Making documents(cGMP)
2019 Domestic cGMP API manufacturer Support qualification (cGMP)
2019 Domestic cGMP API manufacturer Support validation (cGMP)
2019 Domestic cGMP API manufacturer FDA Mock inspection
2019 Domestic cGMP API manufacturer Attend as an observer on inspection by authority
2019 Domestic GMP Pharmaceutical MAH Regulatory support
2019 Domestic GMP API manufacturer Proxy audit of API Manufacturer (GMP)
2019 Overseas Investigational Drug GMP API manufacturer Proxy audit of overseas investigational drug API manufacturer (Investigational Drug GMP)
2019 Domestic GMP Quasi-drug MAH GAP Analysis of overseas pharmaceutical manufacturer (GMP)
2019 Domestic Others API manufacturer Review of DMF Closed Part
2019 Domestic cGMP Pharmaceutical MAH Cosultation of deviation SOP and record (GMP)
2019 Domestic cGMP Pharmaceutical MAH Training of deviation (GMP)
2019 Domestic GMP API manufacturer GMP consulting for API Manufacturer
2019 Domestic GMP Temporary staffing agency GMP traiing
2019 Domestic GMP Temporary staffing agency GMP traiing
2019 Domestic GMP Pharmaceutical MAH Making and Review of PV protocol (GMP)
2019 Domestic GMP Pharmaceutical MAH Making and Review of PV report (GMP)
2019 Domestic GMP Pharmaceutical MAH Preparation for GMP compliance review by PMDA (GMP)
2019 Domestic GMP Pharmaceutical MAH Making and Review of protocol for stability study
2019 Domestic GMP Pharmaceutical MAH Review of stability test result
2019 Domestic GMP Pharmaceutical MAH Self-inspection of Pharmaceutical Manufacturer (GMP)
2019 Domestic GMP Pharmaceutical MAH Attend as an observer on tech-transfer (GMP)
2019 Domestic GMP Pharmaceutical MAH Review of applcation (GMP)
2019 Domestic GMP Pharmaceutical MAH Review of Japanese PIF (GMP)
2019 Domestic GMP Pharmaceutical MAH Review and making support of protocol for tech-transfer (GMP)
2019 Domestic GMP Pharmaceutical MAH Review of tech-transfer (GMP)
2019 Domestic GMP Pharmaceutical MAH Review of Japanese PIF (GMP)
2019 Domestic GMP Pharmaceutical MAH Review of MBR (GMP)
2019 Domestic GMP Pharmaceutical MAH Review of GQP Agreement (GMP)
2019 Domestic GMP Pharmaceutical MAH Review of specification and test method (GMP)
2019 Domestic GMP Pharmaceutical MAH Training for operator (GMP)
2019 Domestic GMP Pharmaceutical MAH Training of testing validation (GMP)
2019 Overseas PMD Act Pharmaceutical MAH Consultation of transfer-approval
2019 Domestic Investigational Drug GMP Medicine manufacturer Review of CAPA plan (Investigational Drug GMP)
2019 Domestic cGMP API manufacturer GAP Analysis (cGMP)
2019 Domestic GDP Logistics company GAP Analysis (GDP)
2019 Domestic cGMP API manufacturer Review of documents for application
2019 Domestic GMP Pharmaceutical MAH GMP training
2019 Domestic GMP Pharmaceutical MAH Construction support of GMP organization (GMP)
2019 Domestic GMP Pharmaceutical MAH Construction support of GMP system (GMP)
2019 Domestic PMD Act Pharmaceutical MAH Application support for licence of pharmaceutical product manufacturer (GMP)
2019 Domestic GMP Pharmaceutical MAH Support fo GMP Compliance Reviews by PMDA
2019 Domestic GMP Foundation Training of practical QC (GMP)
2019 Overseas GMP Pharmaceutical MAH GAP Analysis of overseas pharmaceutical manufacturer (GMP)
2019 Overseas GMP Pharmaceutical MAH Trend lecture of PMDA audit for overseas pharmaceutical manufacturer
2019 Domestic GMP API manufacturer Investigation of GMP documents (GMP)
2019 Domestic Investigational Drug GMP Logistics company Review of CAPA plan (Investigational Drug GMP)
2019 Domestic cGMP API manufacturer cGMP consulting for API Manufacturer
2019 Domestic cGMP API manufacturer Review of PV report (cGMP)
2019 Domestic Investigational Drug GMP Medicine manufacturer Proxy audit of investigational drug manufacturer (Investigational Drug GMP)
2019 Domestic GMP API manufacturer GMP consulting for API Manufacturer
2019 Domestic GMP API manufacturer GMP Ministerial Ordinance training
2019 Domestic GMP API manufacturer GAP Analysis of API Manufacturer (GMP)
2019 Domestic GMP API manufacturer CAPA training (GMP)
2019 Domestic GMP API manufacturer Checking SOPs and records (GMP)
2019 Domestic GMP API manufacturer Review of SOP (GMP)
2019 Domestic GMP API manufacturer GMP consulting for API Manufacturer
2019 Domestic GMP API manufacturer GMP training of API Manufacturer
2019 Domestic GMP API manufacturer GMP improvement support for API Manufacturer
2019 Domestic GMP API manufacturer Proxy audit of API Manufacturer (GMP)
2019 Domestic PMD Act API manufacturer Investigation of development documents
2019 Domestic Investigational Drug GMP Medicine manufacturer Proxy audit of investigational drug manufacturer (Investigational Drug GMP)
2019 Domestic GDP Logistics company Proxy audit of investigational drug storage contractors (GDP)
2019 Domestic GDP Logistics company GDP training
2019 Domestic GDP Logistics company Investigation for constructing GDP organization
2019 Domestic GMP Pharmaceutical MAH Self-inspection of Pharmaceutical Manufacturer (GMP)
2019 Domestic Others API manufacturer Checking requirement based on categorization HPAPI
2019 Domestic Others API manufacturer GAP Analysis of highly Pharmacologically Active API Manufacturer (GMP)
2019 Domestic PMD Act Trading company Training of Pharmaceutical regulation
2019 Domestic Investigational Drug GMP Medicine manufacturer Proxy audit of investigational drug analysis contractor (Investigational Drug GMP)
2019 Domestic GMP API manufacturer GMP training
2018 Domestic cGMP API manufacturer GAP Analysis of API Manufacturer (cGMP)
2018 Domestic cGMP API manufacturer cGMP consulting
2018 Domestic cGMP API manufacturer Review of PV plan (cGMP)
2018 Overseas PMD Act Pharmaceutical MAH Consultation of development and regulation
2018 Domestic GQP Pharmaceutical MAH Support for revision of internal QA regulations
2018 Domestic Investigational Drug GMP Wearhouse company Proxy audit of investigational API manufacturer (Investigational Drug GMP)
2018 Domestic GQP Pharmaceutical MAH Coherent check between SOPs (GMP)
2018 Domestic GMP API manufacturer Review of basic design (GMP)
2018 Domestic GCP Pharmaceutical MAH Making SOP temprate (GCP)
2018 Domestic GCP Pharmaceutical MAH Correction support of SOP (GCP)
2018 Domestic GCP Pharmaceutical MAH GCP training
2018 Domestic GMP Pharmaceutical MAH Operation verification support based on PQS
2018 Domestic GMP Pharmaceutical MAH Operation verification support based on PQS
2018 Domestic GMP Pharmaceutical MAH DI consultation
2018 Domestic PMD Act Pharmaceutical MAH DMF consultation
2018 Domestic Investigational Drug GMP Medicine manufacturer Proxy audit of investigational drug packaging contractor (Investigational Drug GMP)
2018 Domestic GMP Pharmaceutical MAH GMP training (Self-inspection)
2018 Overseas PMD Act Pharmaceutical MAH Regulation consulting
2018 Domestic GMP Pharmaceutical MAH Operation verification support based on PMS
2018 Domestic GMP Pharmaceutical MAH Operation verification support based on PMS
2018 Domestic Investigational Drug GMP API manufacturer Proxy audit of investigational API manufacturer (Investigational Drug GMP)
2018 Domestic GMP API manufacturer Making SOP temprate (GMP)
2018 Domestic GMP API manufacturer Lecture SOP temprate (GMP), and discussion plan
2018 Domestic GMP API manufacturer Review and Q&A SOP (GMP)
2018 Domestic GMP API manufacturer Making SOP temprate (GMP)
2018 Domestic GMP API manufacturer Lecture SOP temprate (GMP), and discussion plan
2018 Domestic GMP API manufacturer Review and Q&A SOP (GMP)
2018 Domestic KGMP Pharmaceutical MAH GAP Analysis of Pharmaceutical Manufacturer (KGMP)
2018 Domestic GMP Foundation GMP training (practical QC)
2018 Domestic GMP Foundation GMP training (basic QC)
2018 Domestic GMP Pharmaceutical MAH Proxy audit of API Manufacturer (GMP)
2018 Domestic EXCiPACT API manufacturer GAP Analysis of pharmaceutical excipients manufacturer (EXCiPACT)
2018 Domestic Investigational Drug GMP API manufacturer Proxy audit of investigational API manufacturer (Investigational Drug GMP)
2018 Domestic GMP Pharmaceutical MAH GMP training
2018 Domestic GMP Pharmaceutical MAH DI training
2018 Domestic GMP Pharmaceutical MAH GMP training (supplier audit)
2018 Overseas GMP API manufacturer GAP analysis of overseas API manufacture (GMP)
2018 Overseas PMD Act Pharmaceutical MAH Research for development and regulation
2018 Domestic GMP Trading company Making GMP documents and operation support
2018 Domestic GMP Trading company Training of SOP (GMP)
2018 Domestic GMP Printing company Seminar of QA for new drug development
2018 Domestic GMP Pharmaceutical MAH Operation verification support based on PQS
2018 Domestic GMP Pharmaceutical MAH Proxy audit of API manufacturer (GMP)
2018 Domestic GDP Certification body Seminar of GDP
2018 Domestic cGMP API manufacturer Mock Inspection of API manufacturer (DI)
2018 Domestic GMP Trading company GAP Analysis of pharmaceutical manufacture (packaging, labeling, storage) (GMP)
2018 Domestic GMP API manufacturer GMP document maintenance and document system reconstruction support
2018 Domestic GMP API manufacturer GMP training
2018 Domestic GMP API manufacturer GMP auditor training
2018 Domestic GQP Pharmaceutical MAH Coherent check between documents and operations(API)
2018 Domestic GQP Pharmaceutical MAH Coherent check between documents and operations(FDF)
2018 Domestic GMP API manufacturer GAP Analysis of API manufacturers (DI)
2018 Overseas GMP Consultant Seminar of PMD Act & GMP
 

 

 
Consulting year Domestic or overseas Regulation Category of company Kind of service
2022 Domestic Others Drug discovery company Support for licensing out of pharmaceutical products
2022 Domestic GCTP Regenerative medicine manufacturer Support in organizing manufacturing and test processes for CPC construction
2022 Domestic GCTP Regenerative medicine manufacturer Basic planning support for CPC construction
2022 Domestic GCTP Regenerative medicine manufacturer Basic design support for CPC construction
2022 Domestic GCTP Regenerative medicine manufacturer Detailed design support for CPC construction
2022 Domestic GMP Regenerative medicine MAH Support for determination of quality requirements for manufacturers of intermediates of combination products for regenerative medicine
2022 Domestic GMP Regenerative medicine MAH Proxy audit of intermediate manufacturing plant for regenerative medicine combination products
2022 Domestic GMP Regenerative medicine MAH Organize requirements and prepare UR for factory build-out
2022 Domestic GMP Regenerative medicine MAH Review of basic design for factory build out
2022 Domestic GMP Regenerative medicine MAH VMP and URS preparation for factory build out
2022 Domestic GMP Regenerative medicine MAH Review of detailed design for factory build out
2022 Domestic GMP Regenerative medicine MAH Preparation of DQ for factory build out
2022 Domestic GMP Regenerative medicine MAH IQ/OQ documentation for factory build out
2022 Domestic GMP Regenerative medicine MAH Advise of PQ for factory build out
2022 Domestic GMP Regenerative medicine MAH Support for improvement of manufacturing facilities for regenerative medical products
2022 Domestic GCTP Regenerative medicine MAH Record review for shipments of regenerative medicine products
2022 Domestic GMP Regenerative medicine MAH Technical training on GMP
2022 Domestic GCP Regenerative medicine MAH Technical training on development
2022 Domestic GCP Regenerative medicine MAH Investigation of the current status of regenerative medicine product development data
2022 Domestic GCTP Regenerative medicine MAH Investigation into the current status of quality assurance for shipments of regenerative medicine products
2022 Domestic Investigational Drug GMP Educational corporation Review of investigational drug manufacturing docymentented manufactuuring orders for investigator-initiated clinical trials
2022 Domestic GCP Regenerative medicine MAH Support for compilation of development data
2022 Domestic GCP Regenerative medicine MAH Support for Risk Assessment
2022 Domestic GCP Regenerative medicine MAH Support for compiling data to determine test criteria and methods
2022 Domestic GCP Regenerative medicine MAH Support for compiling data to determine manufacturing process
2022 Domestic Investigational Drug GMP Regenerative medicine MAH Support for preparation of investigational drug product master formula
2022 Domestic Investigational Drug GMP Regenerative medicine MAH Support for determination of in-process testing and quality test criteria
2022 Domestic Investigational Drug GMP Regenerative medicine MAH Support for Test Method Validation
2022 Domestic Investigational Drug GMP Regenerative medicine MAH Support for investigational drug manufacturing
2022 Domestic GCP Regenerative medicine MAH Training for Drug Product Development
2022 Domestic Investigational Drug GMP Educational corporation Basic traning of Investigational Drug GMP
2022 Domestic Investigational Drug GMP Educational corporation Support for establishment of investigational drug GMP organization for investigator-initiated clinical trials
2022 Domestic Investigational Drug GMP Educational corporation Explanation of GMP PQS Procedures of Investigational New Drugs for Physician-Initiated Clinical Trials
2022 Domestic Investigational Drug GMP Educational corporation Support for development of investigational drug GMP documents for investigator-initiated clinical trials
2022 Domestic GMP Regenerative medicine MAH Validation Implementation Status Investigation for Manufacturing and Testing Facilities
2022 Domestic GMP Regenerative medicine MAH Investigation of regenerative medical product manufacturing facilities
2022 Domestic GMP Regenerative medicine MAH Support for GMP document development for manufacturing of regenerative medicine products
2022 Domestic GMP Regenerative medicine MAH Initial GMP training for manufacturing regenerative medicine products
2022 Domestic PMD Act Regenerative medicine MAH Investigation of the current status of regenerative medicine product development data
2022 Domestic GCTP Educational corporation Documentation Support (GCTP)
2022 Domestic Investigational Drug GMP Educational corporation Support for creating a template for creating procedure manuals (Investigational Drug GMP)
2022 Domestic QMS Regenerative medicine MAH GAP Analysis (QMS)
2022 Domestic PMD Act Regenerative medicine MAH Investigate regenerative medicine combination product development data
2021 Domestic GCTP Educational corporation Support for revision of SOPs (GCTP)
2021 Domestic QSR Medical device MAH GAP analysis in the development of regenerative medicine combination products
2021 Domestic Others Medical device MAH Investigation of development data for regenerative medicine combination products
2021 Domestic QSR Medical device MAH Investigation of regenerative medicine combination product development data for export to the U.S.
2021 Domestic GCTP Regenerative medicine MAH Proxy audits of regenerative medicine products Manufacturer (GCTP)
2021 Domestic Investigational Drug GMP Educational corporation SOP's and record review for regenerative medicine products
2020 Domestic GCTP Regenerative medicine MAH GCTP training
2020 Domestic GCTP Regenerative medicine MAH GAP analysis for a regenerative medicine manufacturer (GCTP)
2021 Domestic GCTP Regenerative medicine MAH GCTP consulting
2020 Domestic GCTP Educational corporation Making SOPs for regenarative medicine's factory (GCTP)
2020 Domestic GCTP Educational corporation GCTP consulting
2020 Domestic GCTP Educational corporation GMP/ GCTP training
2020 Domestic GCTP Educational corporation Making SOPs for regenarative medicine's factory (GCTP)
2020 Domestic GCTP Educational corporation Making SOPs for regenarative medicine's factory (GCTP)
2020 Domestic GCTP Educational corporation Current situation analysis/consultation for regenarative medicine's factory (GCTP)
2020 Domestic GCTP Educational corporation Training of GCTP/GxP for regenarative medicine's factory (GCTP)
2020 Domestic GCTP Educational corporation Making document system diagram for regenarative medicine's factory (GCTP)
2020 Domestic GCTP Educational corporation Making documents for regenarative medicine's factory (GCTP)
2020 Domestic GCTP Educational corporation Review documents for regenarative medicine's factory (GCTP)
2020 Domestic GCTP Educational corporation Confirmation for consistency between documents and operation (GCTP)
2020 Domestic GCTP Regenerative medicine MAH Review for stabiity study report of regenerative medicine (GCTP)
 

 

 
Consulting year Domestic or overseas Regulation Category of company Kind of service
2023 Domestic PMD Act Medical device MAH Support for preparation of application for patical changes documents
2023 Domestic CSV Medical device manufacturer Support for creation of CSV-related business standards
2023 Domestic QMS Medical device MAH Self-inspection of medical device manufacturers (QMS)
2023 Domestic QMS Medical device MAH Consultation for vaccine filling facilities
2022 Domestic CSV Medical device manufacturer Support for SOP creation related to CSV
2022 Domestic QMS Medical device MAH Support for QMS improvement
2022 Domestic QMS Medical device MAH Support for determination of quality requirements for manufacturer of combination products for regenerative medicine etc.
2022 Domestic Others Medical device MAH Support for Stability testing
2022 Domestic CSV Medical device manufacturer Support for CSV document development
2022 Domestic CSV Medical device manufacturer Support for policy discussions for CSV document development
2022 Domestic CSV Medical device MAH Validation plan drafting for QMS management system upgrade
2022 Domestic CSV Medical device MAH Creation of URS for QMS management system upgrade
2022 Domestic CSV Medical device MAH DQ/IQ/OQ document review for QMS management system upgrades
2022 Domestic CSV Medical device MAH PQ documentation and PQ implementation for QMS management system upgrade
2022 Domestic CSV Medical device MAH Validation report preparation for QMS management system upgrade
2022 Domestic CSV Medical device manufacturer Support for the discussion of policies for the development of CSV documentation
2022 Domestic CSV Medical device MAH Validation plan drafting for QMS management system upgrade
2022 Domestic CSV Medical device MAH Creation of URS for QMS management system upgrade
2022 Domestic CSV Medical device MAH DQ/IQ/OQ document review for QMS management system upgrades
2022 Domestic CSV Medical device MAH PQ documentation and PQ implementation for QMS management system upgrade
2022 Domestic CSV Medical device MAH Validation report preparation for QMS management system upgrade
2022 Domestic QMS Cosmetic MAH Proxy audit of medical device storage contractor (QMS)
2022 Domestic CSV Medical device MAH Create and review IQ reports for warehouse management system installation
2022 Domestic CSV Medical device MAH Create and review OQ plan for warehouse management system installation
2022 Domestic CSV Medical device MAH Create and review OQ reports for warehouse management system installation
2022 Domestic CSV Medical device MAH Organize draft operating procedures for warehouse management system installation
2022 Domestic CSV Medical device MAH PQ plan drafting for warehouse management system installation
2022 Domestic CSV Medical device MAH PQ scenario and script drafting for warehouse management system installation
2022 Domestic CSV Medical device MAH Performing PQ for warehouse management system installation
2022 Domestic CSV Medical device MAH Drafting of operational management procedures for warehouse management system installation
2022 Domestic CSV Medical device MAH Prepared validation report for warehouse management system installation
2021 Domestic CSV Medical device MAH CSV verification for ERP installation
2021 Domestic QMS Medical device MAH Review of layout design (QMS)
2021 Domestic CSV Medical device MAH CSV consultation for warehouse management system installation
2021 Domestic QMS Medical device MAH Support for QMS Organization Establishment
2021 Domestic QMS Medical device MAH Construction support of QMS system
2021 Domestic QMS Medical device MAH Construction support of QMS system
2021 Domestic CSV Medical device MAH Review of vendor specifications for ERP system installation
2021 Domestic CSV Medical device MAH Verification of ERP system installation
2021 Domestic QMS Medical device MAH Explanation of QMS overview
2021 Domestic QMS Medical device MAH Review of PQ protocol (QMS)
2021 Domestic QMS Medical device MAH Review of PQ report (QMS)
2021 Domestic QMS Medical device MAH Review of PQ protocol (QMS)
2021 Domestic CSV Medical device MAH CSV consultation for warehouse management system installation
2021 Domestic CSV Medical device MAH Project promotion support for warehouse management system installation
2020 Domestic QMS Medical device MAH Special adviser of medical devices company (QMS)
2020 Domestic CSV Medical device MAH CSV consulting for ERP system installation
2020 Domestic CSV Medical device MAH CSV development documentation for ERP system installation
2020 Domestic CSV Medical device MAH Review of CSV vendor's specifications (QMS)
2020 Domestic CSV Medical device MAH CSV support for ERP system installation (verification)
2019 Domestic QMS Medical device manufacturer GAP Analysis of medical device manufacturer (QMS)
2019 Domestic QMS Medical device manufacturer GAP Analysis of medical device manufacturer (QMS)
2019 Domestic QMS Medical device manufacturer Support of instal QMS (ISO9001/13485)
2019 Domestic QMS Medical device MAH Consultation of Q&A from notify body (ISO13485)
2019 Domestic QMS Medical device MAH Examination support (ISO13485)
2019 Domestic QMS Medical device MAH Examination support (ISO13485)
2019 Domestic QMS Medical device MAH Self-inspection support (ISO13485)
2019 Domestic QMS Medical device MAH Risk management support (ISO13485)
2019 Domestic QMS Medical device MAH Outsourcing study support (ISO13485)
2019 Domestic QMS Medical device MAH QMS support (QMS)
2019 Domestic QMS Medical device MAH Stability study support (QMS)
2019 Domestic QSR Medical device manufacturer QSR & sterilization training (QSR)
2019 Domestic QSR Medical device manufacturer Support for making document system based on QSR & ISO13485
2019 Domestic QSR Medical device manufacturer Support for factory renovation (QSR)
2019 Domestic QSR Medical device manufacturer Supprot for factory validation
2019 Domestic QMS Medical device manufacturer Feasibility study for getting license (QMS)
2019 Domestic QMS Medical device manufacturer Feasibilty study in each regions (ISO13485)
2019 Domestic QMS Medical device manufacturer Lecture of each relulations in the regions (ISO13485)
2019 Domestic QMS Medical device manufacturer GAP Analysis of medical device manufacturer (ISO13485 and regulations)
2019 Domestic QMS Medical device manufacturer Consultion of medical devices development
2019 Overseas QMS Medical device manufacturer Support feasibility study in medical decices industry
2019 Domestic QSR Medical device manufacturer Investigation of structure & equipments
2019 Domestic QSR Medical device manufacturer Making renewal consept design of structure & equipments
2019 Domestic QMS Medical device manufacturer Medical devices consultation
2019 Domestic QSR Medical device MAH Medical devices training
2019 Domestic QSR Medical device MAH Construction support of GMP organization (QMS)
2019 Domestic QSR Medical device MAH Supprort for making documents (QMS)
2019 Domestic QSR Medical device MAH Consultation for making answer against observation (QMS)
2019 Domestic QSR Medical device MAH Consultation for re-examination (QMS)
2019 Domestic PMD Act Medical device MAH Review of application and attachements (QMS)
2019 Domestic PMD Act Medical device MAH Support of PMDA's review (QMS)
2019 Domestic QMS Medical device manufacturer GAP Analysis of medical device manufacturer (QMS)
2019 Domestic QMS Medical device manufacturer DI training (QMS)
2019 Domestic CSV Medical device MAH CSV support for module addition
2019 Domestic QSR Medical device MAH Review and making support of documents (QMS)
2019 Domestic CSV Medical device MAH CSV support for adding QMS management system modules (Project Management)
2019 Domestic QSR Medical device manufacturer GAP Analysis of medical device manufacturer (QSR)
2019 Domestic QSR Medical device MAH GAP Analysis of medical device manufacturer (QSR)
2018 Domestic QSR Medical device MAH Review and making support of documents (CSV)
2018 Domestic CSV Medical device MAH CSV support for adding QMS management system modules (Project Management)
2018 Domestic QMS Medical device MAH Consultation Medical devices business
2018 Domestic QMS Medical device MAH Consultation of Pharmacetuticals/Meical devices business
2018 Overseas GMP Medical device manufacturer Training GMP and engineering
2018 Domestic CSV Medical device manufacturer ER/ES support for core systems
2018 Domestic QMS Medical device MAH Making support of Valdation plan
2018 Domestic QMS Medical device MAH Review of Validation record
2018 Domestic QMS Medical device MAH Attend as an observer on PV
2018 Domestic QMS Medical device MAH Support for selection of vendor/specification
2018 Domestic QMS Medical device MAH Review for validation plan (DQ・IQ・OQ・PQ)
2018 Domestic QMS Medical device MAH Review for validation report (DQ・IQ・OQ・PQ)
2018 Domestic QMS Medical device MAH Attend as an observer on PQ
2018 Domestic QMS Medical device MAH Making SOP support based on ER/ES
 

 

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Consulting year Domestic or overseas Regulation Category of company Kind of service
2023 Domestic cGMP Cosmetic ingredient manufacuturer GMP trainning for API manufacturer
2023 Domestic cGMP Cosmetic ingredient manufacuturer GAP analysis for API manufacturer (cGMP)
2022 Domestic EFfCI Cosmetic ingredient manufacuturer Support for review of proposed product filling room modifications
2022 Domestic Cosmetic GMP Material manufacturer Proxy audit of cosmetics storage contractor(Cosmetic GMP)
2022 Domestic Cosmetic GMP Cosmetic MAH Proxy audit of cosmetics storage contractor(Cosmetic GMP)
2022 Domestic cGMP Cosmetic ingredient manufacuturer cGMP consulting for API manufacturer
2022 Domestic cGMP Cosmetic ingredient manufacuturer cGMP training for API manufacturer
2022 Domestic EFfCI Cosmetic ingredient manufacuturer EFfCI GMP Improvement Consulting for Cosmetics Manufacturer
2022 Domestic PMD Act Medical device MAH Investigation to apply for permission to use colorants in Japan
2022 Domestic Cosmetic GMP Cosmetic MAH Proxy audit(Cosmetic GMP)
2022 Domestic EFfCI Cosmetic ingredient manufacuturer GAP Analysis of Cosmetic Ingredient Manufacturing Plant (EFfCI GMP)
2021 Domestic Cosmetic GMP Cosmetic manufacturer GAP Analysis (Cosmetic GMP)
2021 Domestic cGMP Cosmetic ingredient manufacuturer cGMP training
2021 Domestic cGMP Cosmetic ingredient manufacuturer Consulting on item addition (cGMP)
2021 Domestic cGMP Cosmetic ingredient manufacuturer CSV consulting (cGMP)
2021 Domestic cGMP Cosmetic ingredient manufacuturer Review of CAPA plan (cGMP)
2021 Domestic cGMP Cosmetic ingredient manufacuturer Advice for CAPA plan (cGMP)
2021 Domestic cGMP Cosmetic ingredient manufacuturer Confirmation of improvement status (cGMP)
2020 Domestic EFfCI Cosmetic ingredient manufacuturer GAP Analysis of Cosmetic Ingredient Manufacturer (EFfCI GMP)
2020 Domestic cGMP Cosmetic ingredient manufacuturer FDA Mock inspection of API Manufacturer (cGMP)
2020 Domestic Cosmetic GMP Cosmetic manufacturer GAP Analysis of Cosmetics Manufacturer (Cosmetic GMP)
2020 Domestic cGMP Cosmetic ingredient manufacuturer Making basic engineering design and masterplan of factory construction (cGMP)
2020 Domestic cGMP Cosmetic ingredient manufacuturer Select for factory construction contractor/supplier of factory construction (cGMP)
2020 Domestic cGMP Cosmetic ingredient manufacuturer Making detailed design of factory construction (cGMP)
2020 Domestic cGMP Cosmetic ingredient manufacuturer Construction management (cGMP)
2020 Domestic cGMP Cosmetic ingredient manufacuturer Qualification/Validation of factory construction (cGMP)
2019 Domestic EFfCI Cosmetic ingredient manufacuturer Construction support of GMP organization(EFfCI GMP)
2019 Domestic EFfCI Cosmetic ingredient manufacuturer Support for making document system (EFfCI GMP)
2019 Domestic Cosmetic GMP Cosmetic ingredient manufacuturer Consulting for development of cosmetic ingredient (Cosmetic GMP)
2019 Domestic Cosmetic GMP Cosmetic manufacturer GAP Analysis of Cosmetics Manufacturer (Cosmetic GMP)
2019 Domestic Cosmetic GMP Cosmetic MAH Cosmetic GMP training
2019 Domestic Cosmetic GMP Cosmetic MAH Support for SOP modification (Cosmetic GMP)
2019 Domestic Cosmetic GMP Cosmetic MAH Mock Inspection of Cosmetics Manufacturer (Cosmetic GMP)
2019 Domestic EFfCI Cosmetic ingredient manufacuturer GAP Analysis of Cosmetic Ingredient Manufacturer (EFfCI GMP)
2019 Domestic EFfCI Cosmetic ingredient manufacuturer Investigation of drawing and equimment (EFfCI GMP)
2019 Domestic EFfCI Cosmetic ingredient manufacuturer Training and Q&A of GMP (EFfCI GMP)
2019 Domestic Cosmetic GMP Cosmetic MAH GAP Analysis (CosmeticGMP)
2019 Domestic cGMP Cosmetic ingredient manufacuturer cGMP training
2019 Domestic cGMP Cosmetic ingredient manufacuturer cGMP training
2019 Domestic cGMP Cosmetic ingredient manufacuturer Basic plan/design work support for new factory (cGMP)
2019 Domestic cGMP Cosmetic ingredient manufacuturer Support of making URS for new factory (cGMP)
2019 Domestic cGMP Cosmetic ingredient manufacuturer Validation support for new factory (cGMP)
2019 Domestic CSV Cosmetic ingredient manufacuturer CSV support for new factory (cGMP)
2019 Domestic EFfCI Cosmetic ingredient manufacuturer Making template of SOPs (EFfCI GMP)
2019 Domestic EFfCI Cosmetic ingredient manufacuturer Lecture SOP temprate (EFfCI GMP)
2019 Domestic EFfCI Cosmetic ingredient manufacuturer Review of SOP (EFfCI GMP)
2019 Domestic cGMP Cosmetic ingredient manufacuturer Review of Form 483 (cGMP)
2018 Domestic EFfCI Supplement ingredient manufacturer Investigation of SOPs (EFfCI)
2018 Domestic cGMP Cosmetic ingredient manufacuturer Design review and meeting for new factory construction
2018 Domestic cGMP Cosmetic ingredient manufacuturer Review of validation documents for new factory construction
2018 Domestic Cosmetic GMP Cosmetic manufacturer GAP Analysis of Cosmetics Manufacturer (Cosmetic GMP)
2018 Domestic EXCiPACT Cosmetic ingredient manufacuturer GAP Analysis of pharmaceutical excipients manufacturer (EXCiPACT)
2018 Domestic EFfCI Cosmetic ingredient manufacuturer GAP Analysis of Cosmetic Ingredient Manufacturer (EFfCI GMP)
2018 Domestic CSV Cosmetic ingredient manufacuturer CSV support for DCS installation (Draft of development plan)
2018 Domestic CSV Cosmetic ingredient manufacuturer URS preparation support for DCS installation
2018 Domestic CSV Cosmetic ingredient manufacuturer Support for preparation of validation plan for DCS installations
2018 Domestic CSV Cosmetic ingredient manufacuturer FS preparation support for DCS installation
2018 Domestic CSV Cosmetic ingredient manufacuturer Support for DS document preparation for DCS installation
2018 Domestic CSV Cosmetic ingredient manufacuturer DQ evaluation support for DCS installation
2018 Domestic CSV Cosmetic ingredient manufacuturer IQ documentation and evaluation support for DCS installation
2018 Domestic CSV Cosmetic ingredient manufacuturer OQ documentation and evaluation support for DCS installation
2018 Domestic CSV Cosmetic ingredient manufacuturer PQ document preparation and evaluation support for DCS installation
2018 Domestic CSV Cosmetic ingredient manufacuturer Validation report writing for DCS installation
2018 Domestic EFfCI Cosmetic ingredient manufacuturer EFfCI GMP training
2018 Domestic GCP Cosmetic ingredient manufacuturer Proxy audit of overseas testing outsourcing partners (GCP)
2018 Domestic Cosmetic GMP Cosmetic manufacturer GAP Analysis of cosmetics manufacturers (ISO22716)
2018 Domestic cGMP Cosmetic ingredient manufacuturer cGMP training
 

 

 
Consulting year Domestic or overseas Regulation Category of company Kind of service
2022 Domestic GMP Material manufacturer Creation of Validation Master Plan
2022 Domestic GMP Material manufacturer Review of IOQ Plan/Report
2022 Domestic GMP Material manufacturer Review of PQ Plan/Report
2022 Domestic GMP Material manufacturer Create and review master batch records
2022 Domestic GMP Material manufacturer Review of PV Plan/Report
2022 Domestic GMP Material manufacturer GAP Analysis for Material Manufacturing Plants (GMP)
2022 Domestic GMP Material manufacturer Provide a validation procedure template
2022 Domestic GMP Material manufacturer Investigation of the current status of validation
2022 Domestic GMP Material manufacturer Creation of roadmap for validation (GMP)
2022 Domestic GMP Material manufacturer Support for preliminary study of equipment and facilities for new factory
2022 Domestic GMP Material manufacturer Support for preliminary study of packaging specifications
2022 Domestic GMP Material manufacturer Support for preliminary study of manufacturing process
2021 Domestic GMP Material manufacturer Investigations of the current plant for the construction of a new plant
2021 Domestic GMP Material manufacturer Support for preliminary study of equipment and facilities for new factory
2021 Domestic GMP Material manufacturer Support for preliminary study of packaging specifications
2021 Domestic GMP Material manufacturer Support for preliminary study of manufacturing process
2021 Domestic GMP Material manufacturer GMP training
2021 Domestic GMP Material manufacturer Consultation for Construction of Rubber Plug Manufacturing Plant
2019 Domestic QMS Medical device manufacturer Feasibility study support of layout (QMS)
2019 Domestic QMS Medical device manufacturer Consulting way of sterilization, and suitable equipment (QMS)
2019 Domestic QMS Medical device manufacturer Support of line layout (QMS)
2019 Domestic QMS Medical device manufacturer Support for estimation of cost (QMS)
2019 Domestic QMS Medical device manufacturer Basic training of Medical Devices (QMS)
2019 Domestic QMS Medical device manufacturer Feasibility study support (QMS)
 

 

 
Consulting year Domestic or overseas Regulation Category of company Kind of service
2022 Domestic GMP Construction company Engineering support for warehouse construction
2021 Domestic GMP Construction company Basic design support for the construction of an injectable drug manufacturing plant
2021 Domestic GMP Construction company Detailed design support for the construction of an injectable drug manufacturing plant
2021 Domestic GMP Construction company Design review and meeting regarding warehouse construction (GMP)
2021 Domestic GMP Construction company Specification review and meetings regarding warehouse construction
2021 Domestic GMP Construction company IOQ document review and meetings regarding warehouse construction
2021 Domestic CSV Construction company CSV document review and meetings for warehouse construction
2021 Domestic GMP Construction company Competition support as an inner consultant (GMP)
2020 Domestic GMP Construction company Special adviser of construction company for getting construction project in pharmaceutical industry (GMP)
2019 Domestic GMP Construction company Competition support as an inner consultant (GMP)
2019 Domestic Cosmetic GMP Construction company Basic plan support (ISO22716)
2019 Domestic cGMP Construction company cGMP training
 

 

 
Consulting year Domestic or overseas Regulation Category of company Kind of service
2023 Domestic GMP Equipment sales company Training for equipment manufacturers about validation
2023 Domestic GMP Equipment sales company Validation consulting for equipment manufacturer
2023 Domestic GMP Equipment sales company Training for equipment manufacturers about validation
2023 Domestic GMP Equipment sales company Validation consulting for equipment manufacturer
2022 Domestic CSV Equipment sales company Consultation on CSV support for image inspection equipment (GMP)
2022 Domestic CSV Equipment sales company Provide supplier written audit list in CSV for imaging inspection equipment
2022 Domestic CSV Equipment sales company Provide ER/ES and Part 11 checklists
2022 Domestic QMS Equipment sales company Validation training for equipment suppliers
2022 Domestic QMS Equipment sales company Support for creation of validation documentation for imaging inspection equipment (DQ, IQ, OQ)
2022 Domestic QMS Equipment sales company Support for Validation Document Review of Imaging and Inspection Equipment (DQ)
2022 Domestic QMS Equipment sales company Support for consultation on validation of imaging inspection equipment
2021 Domestic GMP Equipment sales company Validation training for equipment suppliers
2021 Domestic cGMP Equipment sales company Validation training for equipment manufacturers (cGMP)
2021 Domestic QMS Equipment sales company Validation training for equipment manufacturers (QMS)
2019 Domestic GMP Equipment sales company Consultation for development of medical devices
 

 

 
Consulting year Domestic or overseas Regulation Category of company Kind of service
2023 Domestic GMP Pharmaceutical MAH Creation of audit checklist (GMP)
2023 Domestic GMP Medicine manufacturer Proxy audits of pharmaceutical manufacture (GMP)
2022 Domestic GMP Analysis company GAP analysis of laboratory (GMP)
2022 Domestic GMP Event company DI Seminar
2022 Domestic CSV Clinical laboratory testing company CSV document drafting for installation of maintenance management system
2022 Domestic CSV Clinical laboratory testing company CSV document review for maintenance management system installation
2021 Domestic CSV Clinical laboratory testing company CSV documentation support for installation of a scratch system
2021 Domestic CSV Clinical laboratory testing company Risk assessment support for installation of a scratch system
2021 Domestic CSV Clinical laboratory testing company Validation report review for installation of a scratch system
2021 Domestic CSV Clinical laboratory testing company CSV documentation support for the installation of a scratch system
2021 Domestic CSV Clinical laboratory testing company Risk assessment support for installation of a scratch system
2021 Domestic CSV Clinical laboratory testing company Validation report review for installation of a scratch system
2021 Domestic CSV Clinical laboratory testing company CSV consulting for installation of a scratch system
2021 Domestic CSV Clinical laboratory testing company Creation of a validation plan for the installation of a scratch system
2020 Domestic PMD Act Quasi-drug MAH Consultation for application of quasi-drug
2020 Overseas PMD Act Cosmetic MAH Research of regulation in Japan against medicated toothpaste from overseas country
2020 Overseas PMD Act Cosmetic MAH Research of how-to register as quasi-drug in Japan against medicated toothpaste from overseas country
2020 Overseas PMD Act Cosmetic MAH Research of how-to import medicated toothpasete in Japan from overseas country
2020 Overseas PMD Act Cosmetic MAH Research of claim/advertisement risk in Japan against medicated toothpasete from overseas country
2020 Domestic CSV Clinical laboratory testing company CSV consulting for installation of a scratch system
2020 Domestic CSV Clinical laboratory testing company CSV documentation support for installation of a scratch system
2019 Domestic GMP Event company DI seminar
2019 Domestic GMP Consultant GMP seminar
2019 Domestic Others Event company API Supply Chain Management seminar (GQP)
2019 Domestic QMS Foundation Automatic recognition system seminar (QMS)
2019 Domestic CSV Clinical laboratory testing company CSV consulting for installation of a scratch system
2019 Domestic CSV Clinical laboratory testing company Review of CSV documentation in the installation of a scratch system
2019 Overseas PMD Act Consultant Investigation of Quasi-drugs regulation
2019 Domestic GMP Analysis company GMP consulting
2019 Domestic GMP Analysis company GAP Analysis of analysis contractor (GMP)
2019 Domestic GMP Consultant GMP seminar
2018 Domestic GMP Consultant GMP seminar
2018 Domestic CSV Clinical laboratory testing company URS creation support for QMS management system installation
2018 Domestic CSV Clinical laboratory testing company Review of vendor documentation for QMS management system installation
2018 Domestic CSV Clinical laboratory testing company Support for preparation of validation plans for QMS management system installations
2018 Domestic CSV Clinical laboratory testing company PQ support for QMS management system installation
2018 Domestic CSV Clinical laboratory testing company Support for preparation of project reports for QMS management system installation
2018 Domestic CSV Clinical laboratory testing company System training for QMS management system installation
2018 Domestic GMP Temporary staffing agency Attend as an observer on GMP seminar
 

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