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 |
""
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 |