Performance list (2020 - 2024)
MAH : Marketing authorization holder
API : Active Pharmaceutical Ingredient
CSV:Computerized system validation
| Consulting year | Domestic or overseas | Regulation | Category of company | Kind of service |
|---|---|---|---|---|
| 2024 | Domestic | GMP | Medicine manufacturer | Support for proxy audit representation of API manufacturing facilities in India |
| 2024 | Domestic | GMP | Pharmaceutical MAH | GAP Analysis of formulation plants (GMP) |
| 2024 | Domestic | GMP | Pharmaceutical MAH | GAP Analysis of Injectable Drug Plants (GMP) |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Mock inspection (remote) of formulation plants |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Training for GMP compliance inspection |
| 2024 | Domestic | Others | Pharmaceutical MAH | Research and training seminars on Chinese laws and regulations |
| 2024 | Domestic | Others | API manufacturer | Consultation on containment of genotoxic agents |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Quality evaluation by inspection of tablets |
| 2024 | Domestic | GMP | Medicine manufacturer | GMP Compliance Investigation of Pharmaceutical Manufacturing Facilities |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Interpretation support for overseas manufacturing facility audits (English/Japanese) |
| 2024 | Domestic | PMD Act | Pharmaceutical MAH | Suport for translation of CTD |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Support for PTP packaging of pharmaceutical products |
| 2024 | Domestic | Others | Pharmaceutical MAH | Support for the preparation of preliminary stability testing protocols |
| 2024 | Domestic | Others | Pharmaceutical MAH | Confirmation of preliminary stability testing results |
| 2024 | Domestic | GMP | API manufacturer | Consultation on manufacturing control and quality control |
| 2024 | Domestic | GMP | API manufacturer | GMP Consulting (April-August 2024) |
| 2024 | Domestic | Investigational Drug GMP | Pharmaceutical MAH | Proxy audits for Investigational New Drug manufacturer(Investigational New Drug GMP) |
| 2024 | Domestic | GMP | Medicine manufacturer | GMP annual training (5 times in total) |
| 2024 | Domestic | PMD Act | Pharmaceutical MAH | Revew for CTD(M2.3) |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Research for manufacturing transfer |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Assist in reviewing drawings for pharmaceutical plant renovations |
| 2024 | Domestic | GMP | Medical device MAH | Support for GMP GAP analysis of QMS system |
| 2024 | Domestic | GMP | Medicine manufacturer | GMP training support for education and training personnel |
| 2024 | Domestic | Others | Pharmaceutical MAH | Support for Stability Testing |
| 2024 | Domestic | GMP | API manufacturer | Consultation on sampling methods |
| 2024 | Domestic | Investigational Drug GMP | Pharmaceutical MAH | Support for proxy audit of API manufacturing sites in China (Investigational new drug GMP) |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Audit interpretation support for pharmaceutical wholesaler warehouses |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Consultation on formulation application |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Confirmation and evaluation of stability testing results for PTP packaging and assistance with preliminary stability testing |
| 2024 | Domestic | CSV | System company | Scope study on the implementation of a production management system |
| 2024 | Domestic | GMP | Pharmaceutical MAH | GMP audit training (API) |
| 2024 | Domestic | GMP | Pharmaceutical MAH | On-site consulting for QC operations |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Support for advance preparation of inquiries for drug manufacturing and marketing approval |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Interpretation support for audits to select contractors |
| 2024 | Domestic | GMP | Medicine manufacturer | GAP analys of pharmacutical manufacturing facility |
| 2024 | Domestic | Investigational Drug GMP | Medicine manufacturer | Proxy audits of domestic CPC facilities |
| 2024 | Domestic | GMP | Drug discovery company | Support for analyzing the current situation and drafting a Roadmap for development |
| 2024 | Domestic | GMP | Drug discovery company | Initial survey of manufacturing facility (Laboratory) |
| 2024 | Domestic | GMP | API manufacturer | GMP Consulting (Sep 2024-Mar 2025) |
| 2024 | Domestic | GMP | Architectural Design Company | Training for GMP |
| 2024 | Domestic | GMP | Architectural Design Company | Support for laboratory facility evaluations |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Support for proxy audits of manufacturing facilities |
| 2024 | Domestic | PMD Act | Pharmaceutical MAH | Support for scheduling stability tests |
| 2024 | Domestic | PMD Act | Pharmaceutical MAH | Support for obtaining stability test specimens and standards |
| 2024 | Domestic | Others | Pharmaceutical MAH | Support for coordination with packaging/testing contractors |
| 2024 | Domestic | PMD Act | Pharmaceutical MAH | Support for validation of microbiological tests |
| 2024 | Domestic | PMD Act | Pharmaceutical MAH | Support for preparation of stability test protocols |
| 2024 | Domestic | PMD Act | Pharmaceutical MAH | Review of accelerated test results report |
| 2024 | Domestic | PMD Act | Pharmaceutical MAH | Review of Long-term shelf-life testing result reports |
| 2024 | Domestic | PMD Act | Pharmaceutical MAH | Support for development of CTD M2.3 and M3 preparation policy |
| 2024 | Domestic | PMD Act | Pharmaceutical MAH | Support for CTD M2.3 preparation |
| 2024 | Domestic | PMD Act | Pharmaceutical MAH | Support for CTD M3 preparation |
| 2024 | Domestic | PMD Act | Pharmaceutical MAH | CTD M1 document draft review support |
| 2024 | Domestic | PMD Act | Pharmaceutical MAH | Consultation support for CTD preparation (including reporting) |
| 2024 | Domestic | PMD Act | Pharmaceutical MAH | Support for proxy audit of testing contractors [Reliability standards]. |
| 2024 | Domestic | PMD Act | Pharmaceutical MAH | Support for preparation of documentary research materials |
| 2024 | Domestic | PMD Act | Pharmaceutical MAH | Support for responding to PMDA inquiries (M2.3,M3) |
| 2024 | Overseas | GMP | Pharmaceutical MAH | Pre-audit for overseas API manufacturers |
| 2024 | Overseas | GMP | Pharmaceutical MAH | Pre-audit for overseas formulation manufacturers |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Pre-audit for domestic packaging contractors |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Pre-audit for domestic testing contractors |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Review of audit results improvement plans and reports |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Preparation for GMP compliance inspection |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Support for mock inspections of overseas API manufacturers |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Support for mock inspections of overseas formulation manufacturers |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Mock inspections of domestic packaging contractors |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Mock inspections of domestic testing contractors |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Improvement plans and responses to reports on issues raised following GMP compliance inspections |
| 2024 | Domestic | Others | Pharmaceutical MAH | Support for development of a proposal for the establishment of a new department |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Proxy audit of pharmaceutical manufacturer (GMP) |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Support for drafting instruction |
| 2024 | Domestic | Others | Pharmaceutical MAH | Consultation on policy for MAH certification |
| 2024 | Domestic | GQP | Pharmaceutical MAH | Support for creating procedures for MAH certification |
| 2024 | Domestic | Others | Pharmaceutical MAH | Recruiting Support |
| 2024 | Domestic | PMD Act | Pharmaceutical MAH | Review of Drug Approval Applications |
| 2024 | Domestic | Investigational Drug GMP | Pharmaceutical MAH | Support for evaluation of suppliers regarding the introduction of investigational new drugs |
| 2024 | Domestic | Investigational Drug GMP | Pharmaceutical MAH | Support for quality assessment of investigational new drugs |
| 2024 | Domestic | Investigational Drug GMP | Pharmaceutical MAH | Support for creating investigational product master formula |
| 2024 | Domestic | Investigational Drug GMP | Pharmaceutical MAH | Support for release decision from overseas manufacturing facilities |
| 2024 | Domestic | Investigational Drug GMP | Pharmaceutical MAH | Packaging company's production of investigational drugs is evaluated. |
| 2024 | Domestic | Others | Pharmaceutical MAH | Quality control of investigational new drugs (up to in-licensing of investigational new drugs) |
| 2024 | Domestic | PMD Act | Trading company | Consultation support regarding related substances |
| 2024 | Domestic | Others | Regenerative medicine MAH | Review of quality contracts |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Support for mock inspections of overseas API manufacturers |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Support for mock inspections of overseas formulation manufacturers |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Mock inspections of domestic packaging and testing contractors |
| 2024 | Domestic | Others | Pharmaceutical MAH | Quality contract review of overseas manufacturing facilities (APIs and drug product) |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Review of product specifications |
| 2024 | Domestic | Others | Pharmaceutical MAH | Support for review of quality contracts for domestic manufacturing facilities |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Support for review and finalization of quality contracts |
| 2024 | Domestic | GQP | Pharmaceutical MAH | Support for review of procedures related to the manufacture and marketing authorsation of pharmaceutical products |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Training of training personnel for GMP education |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Support for drafting instruction |
| 2024 | Domestic | GMP | Trading company | Interpretation for audits of overseas API manufacturing facilities |
| 2024 | Domestic | Others | Pharmaceutical MAH | CMC consultation for development candidates |
| 2024 | Overseas | Others | Medicine manufacturer | Proxy audits of API Manufacturer (GMP) |
| 2024 | Domestic | PMD Act | Pharmaceutical MAH | Pharmaceutical consultation regarding relocation of contractors |
| 2024 | Domestic | PMD Act | Trading company | Consultation for Master File Creation |
| 2024 | Domestic | GMP | Trading company | Support for creation of OOS procedures |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Proxy audits of pharmaceutical manufacture (GMP) |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Support for drafting instruction |
| 2024 | Domestic | PMD Act | Trading company | Review of Master File |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Proxy audits of starting material manufacturing facilities |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Proxy audits of starting material manufacturing facilities |
| 2024 | Domestic | cGMP | Pharmaceutical MAH | Evaluation of Job Description and Education System |
| 2024 | Domestic | GMP | Trading company | Proxy audits for overseas API manufacturer (GMP) |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Consulting for GMP, QMS, pharmaceutical regulations, etc. |
| 2024 | Domestic | PMD Act | Pharmaceutical MAH | Consultation for changes in laboratory test methods |
| 2024 | Domestic | PMD Act | Pharmaceutical MAH | Consultation for Manufacturing Businesses for Medical Devices |
| 2024 | Domestic | GMP | Regenerative medicine MAH | GMP audit of overseas manufacturing sites (Desktop) |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Consultation on Analytical Method Validation |
| 2024 | Domestic | PMD Act | Pharmaceutical MAH | Consultation for packaging and labeling |
| 2024 | Domestic | cGMP | Pharmaceutical MAH | GAP Analysis of API Manufacturer (cGMP) |
| 2024 | Domestic | Others | Pharmaceutical MAH | Regulatory Studies in Asia |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Support for drafting instruction |
| 2024 | Domestic | GMP | Pharmaceutical MAH | Support for drafting instruction |
| 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 |
| 2023 | Domestic | GMP | System company | GMP Seminar |
| 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 | CSV | Medicine manufacturer | CSV Training |
| 2023 | Domestic | GMP | Pharmaceutical MAH | Review of validation documents |
| 2023 | Domestic | GMP | Pharmaceutical MAH | Support for revision of master batch records |
| 2023 | Domestic | GMP | Pharmaceutical MAH | Support for creating procedures related to manufacturing equipment |
| 2023 | Domestic | GMP | Pharmaceutical MAH | GMP document inspection |
| 2023 | Domestic | GMP | Pharmaceutical MAH | GMP document Revision |
| 2023 | Domestic | GMP | Medicine manufacturer | Proxy audits for Pharmaceutical manufacturer (Investigational Drug GMP) |
| 2023 | Domestic | GMP | Medicine manufacturer | Support for survey of current conditions for vector production |
| 2023 | Overseas | GMP | Medicine manufacturer | Proxy audits for overseas manufacturer (GMP) |
| 2023 | Domestic | GMP | Pharmaceutical MAH | Consultation on contract manufacturing management |
| 2023 | Domestic | GMP | Pharmaceutical MAH | GAP Analysis of Pharmaceutical Manufacturer |
| 2023 | Domestic | Investigational Drug GMP | Medicine manufacturer | Consultation on manufacturing of APIs for clinical trials |
| 2023 | Domestic | GMP | API manufacturer | GMP consulting for API manufacturer |
| 2023 | Domestic | cGMP | Medicine manufacturer | Mock audit of investigational drug manufacturing plant (injectable drug) |
| 2023 | Domestic | GMP | Pharmaceutical MAH | Evaluation of manufacturing line drawings for high pharmacological formulation |
| 2023 | Domestic | GMP | Medicine manufacturer | Training for aseptic formulation（PIC/S ANEEX1） |
| 2023 | Domestic | GMP | Medicine manufacturer | Training for technology transfer |
| 2023 | Domestic | GMP | Medicine manufacturer | Training for compliance in pharmaceutical manufacturing |
| 2023 | Domestic | GMP | Medicine manufacturer | Training for DI |
| 2023 | Domestic | CSV | Medicine manufacturer | Training for CSV guidelines |
| 2023 | Domestic | GMP | Medicine manufacturer | Review of basic and detailed design documents for the construction of pharmaceutical manufacturing plant |
| 2023 | Domestic | GMP | Medicine manufacturer | FAT surpport for preparation 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 IOQ plan review of pharmaceutical manufacturing plant |
| 2023 | Domestic | GMP | Medicine manufacturer | Support for DQ plan preparation of pharmaceutical manufacturing plant |
| 2023 | Domestic | PMD Act | Pharmaceutical MAH | Consultation on product labels for pharmaceutical Drug Product |
| 2023 | Domestic | GMP | Medicine manufacturer | Research support for Reconstruction of pharmaceutical production area |
| 2023 | Domestic | GMP | Medicine manufacturer | GAP analysis for pharmaceutical manufacturer (GMP) |
| 2023 | Domestic | GMP | API manufacturer | Audit for Quality Management System for API manufacturer |
| 2023 | Domestic | GVP | Pharmaceutical MAH | Sales of GVP procedures |
| 2023 | Domestic | Investigational Drug GMP | Medicine manufacturer | Consultation on investigational drug stability testing |
| 2023 | Domestic | PMD Act | Pharmaceutical MAH | Consultation and evaluation of PTP sheets |
| 2023 | Domestic | GMP | Pharmaceutical MAH | Review of CTD |
| 2023 | Domestic | GMP | API manufacturer | On-the-job training for self-inspection |
| 2023 | Domestic | GMP | API manufacturer | Training for self-inspection |
| 2023 | Domestic | Others | Pharmaceutical MAH | Consultation for pharmaceutical business |
| 2023 | Domestic | cGMP | API manufacturer | Training for cGMP |
| 2023 | Domestic | GMP | Pharmaceutical MAH | Comprehensive consulting for pharmaceuticals |
| 2023 | Domestic | cGMP | Pharmaceutical MAH | Organization/Design of Job Descriptions |
| 2023 | Domestic | cGMP | Pharmaceutical MAH | Organization/design of training records |
| 2023 | Domestic | cGMP | Pharmaceutical MAH | Organization/design of training programs |
| 2023 | Domestic | GMP | Trading company | Consulting on API quantification methods |
| 2023 | Domestic | PMD Act | Pharmaceutical MAH | Support for FD application data review |
| 2023 | Domestic | PMD Act | Pharmaceutical MAH | Support for pharmaceutical consultation regarding M1.2 |
| 2023 | Domestic | GMP | Medicine manufacturer | Support for aseptic manufacturing area reconstruction layout study |
| 2023 | Domestic | GMP | Medicine manufacturer | Support for preparation of conceptual design for reconstruction of the sterile drug product manufacturing area |
| 2023 | Domestic | GMP | Medicine manufacturer | Support for investigation of estimated cost for reconstruction of the sterile drug product manufacturing area |
| 2023 | Domestic | GMP | Pharmaceutical MAH | Virtual GMP audit training (Sterile Medical Products) |
| 2023 | Overseas | GMP | Foundation | PMDA Mock Inspection of Overseas pharmaceutical Manufacturer (GMP) |
| 2023 | Domestic | GQP | Pharmaceutical MAH | Referral assistance for General Marketing compliance Officer |
| 2023 | Domestic | PMD Act | Pharmaceutical MAH | Pharmaceutical consultation for drug additives |
| 2023 | Domestic | GMP | API manufacturer | FDA Mock inspection of API Manufacturer (cGMP) |
| 2023 | Domestic | GMP | Pharmaceutical MAH | Proxy audits of pharmaceutical manufacture (GMP) |
| 2023 | Domestic | GMP | Pharmaceutical MAH | Proxy audits for overseas API manufacturer (GMP) |
| 2023 | Domestic | GMP | Pharmaceutical MAH | Proxy audits for overseas manufacturer (GMP) |
| 2023 | Domestic | GMP | Pharmaceutical MAH | Proxy audits for overseas manufacturer (GMP) |
| 2023 | Domestic | cGMP | Medicine manufacturer | Support for consideration of education and training management methods |
| 2023 | Domestic | cGMP | Medicine manufacturer | Transition to a document management system for training records etc |
| 2023 | Domestic | cGMP | Medicine manufacturer | Prepare/provide training materials for responsible personnel |
| 2023 | Domestic | cGMP | Medicine manufacturer | Deployment/confirmation of job description |
| 2023 | Domestic | GMP | Trading company | Self-inspection at warehouse facilities(Packaging, labeling, storage) |
| 2023 | Domestic | PMD Act | Pharmaceutical MAH | Pharmaceutical consultation for reference material |
| 2023 | Domestic | PMD Act | Pharmaceutical MAH | Consultation for contract laboratory |
| 2023 | Domestic | GMP | Pharmaceutical MAH | Support for research on development data |
| 2023 | Domestic | PMD Act | Pharmaceutical MAH | Pharmaceutical Affairs Consultation for Excipients |
| 2023 | Domestic | GMP | Medicine manufacturer | Consultation for manufacturing API |
| 2023 | Domestic | GMP | API manufacturer | Support for LIMS implementation |
| 2023 | Domestic | cGMP | API manufacturer | Training for cGMP |
| 2023 | Domestic | cGMP | API manufacturer | FDA Inspection Training |
| 2023 | Domestic | cGMP | API manufacturer | Support for handling findings during FDA mock inspections |
| 2023 | Domestic | cGMP | API manufacturer | Check deviation/change control, OOS/OOT, and validation records |
| 2023 | Domestic | cGMP | API manufacturer | FDA Mock Inspections for API Plant |
| 2023 | Domestic | GMP | Trading company | Periodic GMP proxy audit on behalf of API plants in China |
| 2023 | Domestic | GMP | Trading company | First GMP proxy audit on behalf of API plants in China |
| 2023 | Domestic | GMP | Trading company | Proxy audit of API Manufacturing Facility in India |
| 2023 | Domestic | Investigational Drug GMP | Pharmaceutical MAH | Evaluation of Investigational New Drug Supplier |
| 2023 | Domestic | Investigational Drug GMP | Pharmaceutical MAH | Quality Assessment of Investigational New drug |
| 2023 | Domestic | Investigational Drug GMP | Pharmaceutical MAH | Preparation of documents related to the investigational new drug |
| 2023 | Domestic | Investigational Drug GMP | Pharmaceutical MAH | Investigational new drug transport mode study |
| 2023 | Domestic | Investigational Drug GMP | Pharmaceutical MAH | Examination of domestic packaging and labeling specifications for investigational new drug |
| 2023 | Domestic | Investigational Drug GMP | Pharmaceutical MAH | Audit of packaging contractors for investigational new drugs |
| 2023 | Domestic | Investigational Drug GMP | Pharmaceutical MAH | Preparation of Quality Arrangements |
| 2023 | Domestic | Investigational Drug GMP | Pharmaceutical MAH | Management of importation and storage of pharmaceutical products on behalf of the company |
| 2023 | Domestic | Investigational Drug GMP | Pharmaceutical MAH | Management of packaging, storage, and delivery of investigational drugs on behalf of the company |
| 2023 | Domestic | Investigational Drug GMP | Pharmaceutical MAH | Support for establishment of procedures for investigational new drugs GMP |
| 2023 | Domestic | Investigational Drug GMP | Pharmaceutical MAH | Quality control operations on behalf of the company |
| 2023 | Domestic | GMP | Pharmaceutical MAH | Pharmaceutical Affairs consultation on packaging |
| 2023 | Domestic | GMP | Pharmaceutical MAH | Support for responding to PMDA inquiries |
| 2023 | Domestic | GMP | Quasi-drug MAH | Conslutation on quasi-drug |
| 2023 | Domestic | PMD Act | Pharmaceutical MAH | Support for responding to PMDA inquiries |
| 2022 | Domestic | Others | API manufacturer | Support for registration with the U.S. DMF |
| 2022 | Domestic | GMP | Trading company | GMP Training for Management |
| 2022 | Domestic | GMP | Medicine manufacturer | Proxy for paper audit (GMP) |
| 2022 | Domestic | PMD Act | Trading company | Investigation to set specifications |
| 2022 | Domestic | GMP | Medicine manufacturer | GAP analysis of pharmaceutical Manufacturer (EU GMP) |
| 2022 | Domestic | GMP | Medicine manufacturer | Support for SOP restructuring study (GMP) |
| 2022 | Domestic | GMP | Medicine manufacturer | Interpretation support for pharmaceutical-related business |
| 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 | Investigational Drug GMP | Medicine manufacturer | GAP Analysis (Investigational Drug GMP) |
| 2022 | Domestic | GMP | API manufacturer | GAP analysis of API manufacturer (GMP) |
| 2022 | Domestic | CSV | Pharmaceutical MAH | Review of system specifications for installation of a scratch system |
| 2022 | Overseas | GMP | Pharmaceutical MAH | Interpretation for PMDA remote inspections of overseas API manufacturing sites |
| 2022 | Domestic | GMP | Medicine manufacturer | Proxy for paper audit of overseas API manufacturer (GMP) |
| 2022 | Domestic | PMD Act | Regenerative medicine MAH | Support for evaluation of elemental impurities (ICH Q3D) |
| 2022 | Overseas | GMP | APIs intermediates manufacturer | GMP consulting for API intermediate manufacturer |
| 2022 | Overseas | GMP | Pharmaceutical MAH | Interpretation for PMDA remote inspections of overseas API manufacturer |
| 2022 | Domestic | cGMP | Medicine manufacturer | GAP analysis for laboratories (cGMP) |
| 2022 | Domestic | GMP | Medicine manufacturer | CAPA Plan Review of GAP Analysis Findings |
| 2022 | Domestic | GMP | Medicine manufacturer | GMP training |
| 2022 | Domestic | CSV | Pharmaceutical MAH | URS Review for Scratch System Installation |
| 2022 | Domestic | GMP | Medicine manufacturer | GAP analysis of GMP procedures |
| 2022 | Domestic | GMP | Pharmaceutical MAH | Proxy audits of pharmaceutical manufacture (GMP) |
| 2022 | Domestic | CSV | API manufacturer | Advice for warehouse management system installation |
| 2022 | Domestic | GMP | API manufacturer | Support for cleaning validation of common equipment |
| 2022 | Domestic | GMP | API manufacturer | Support for establishment of pharmaceutical quality system |
| 2022 | Domestic | GMP | API manufacturer | GMP Consulting |
| 2022 | Domestic | GMP | API manufacturer | GMP training |
| 2022 | Domestic | PMD Act | Medical device MAH | Evaluation of Elemental Impurities |
| 2022 | Domestic | GMP | Medicine manufacturer | Support the creation of Transport Verification documentationand execution |
| 2022 | Domestic | GMP | Medicine manufacturer | Support for sterilization validation documentation and execution |
| 2022 | Domestic | GMP | Medicine manufacturer | Support forGrowth Promotion Test documentation and execution |
| 2022 | Domestic | GMP | Medicine manufacturer | Support for PQ documentation and execution of equipment and facilities |
| 2022 | Domestic | GMP | Medicine manufacturer | Support for temperature mapping documentation and execution |
| 2022 | Domestic | GMP | Medicine manufacturer | Creation of Validation Master Plan |
| 2022 | Domestic | GMP | Medicine manufacturer | Instruction on equipment calibration and periodic inspections |
| 2022 | Domestic | GMP | Medicine manufacturer | Support for environmental validation documentation and execution |
| 2022 | Domestic | GMP | Medicine manufacturer | Support for revalidation of relocated equipments |
| 2022 | Domestic | GMP | Medicine manufacturer | Support for preparation of tertiary documents related for GMP |
| 2022 | Overseas | GMP | Trading company | Proxy audits for overseas API manufacturer (GMP) |
| 2022 | Domestic | CSV | System company | CSV training for system vendors |
| 2022 | Overseas | GMP | Medicine manufacturer | Proxy audits of API Manufacturer (GMP) |
| 2022 | Overseas | GMP | Medicine manufacturer | PMDA Mock Inspection of Overseas Biological Drug Manufacturing Sites |
| 2022 | Domestic | GMP | Medicine manufacturer | Consultation for Reference Standard |
| 2022 | Domestic | Investigational Drug GMP | Medicine manufacturer | Proxy audit of investigational drug manufacturer (Investigational Drug GMP) |
| 2022 | Domestic | CSV | Medicine manufacturer | Creation of Validation Master Plan |
| 2022 | Domestic | CSV | Medicine manufacturer | Creation of URS |
| 2022 | Domestic | CSV | Medicine manufacturer | IQ/OQ surpport |
| 2022 | Domestic | CSV | Medicine manufacturer | FAT surpport |
| 2022 | Domestic | CSV | Medicine manufacturer | DQ surpport |
| 2022 | Domestic | CSV | Medicine manufacturer | CSV report preparation |
| 2022 | Domestic | PMD Act | Pharmaceutical MAH | Making MF draft |
| 2022 | Domestic | GMP | Pharmaceutical MAH | Training about MF |
| 2022 | Domestic | Investigational Drug GMP | Medicine manufacturer | Development support in investigational drug manufacturing |
| 2022 | Domestic | GMP | Trading company | Training of management on pharmaceutical quality systems |
| 2022 | Domestic | cGMP | Medicine manufacturer | Support for evaluation of cGMP compliance for export of investigational API to the U.S. |
| 2022 | Domestic | Others | Pharmaceutical MAH | Consultation for contamination with foreign materials |
| 2022 | Domestic | PMD Act | Pharmaceutical MAH | Consultation for tablet imprinting |
| 2022 | Domestic | Others | Medicine manufacturer | Serialization Overview Training |
| 2022 | Domestic | CSV | Pharmaceutical MAH | Support for review of validation plan for scratch system implementation |
| 2022 | Domestic | GMP | Pharmaceutical MAH | Support on supplier audits of scratch system implementation |
| 2022 | Domestic | CSV | Pharmaceutical MAH | URS review support for scratch system implementation |
| 2022 | Domestic | CSV | Pharmaceutical MAH | Support for OQ review scratch system implementation |
| 2022 | Domestic | CSV | Pharmaceutical MAH | Support for IQ review scratch system implementation |
| 2022 | Domestic | CSV | Pharmaceutical MAH | Support for DQ review of scratch system implementation |
| 2021 | Domestic | GQP | Trading company | GQP consulting |
| 2021 | Domestic | Investigational Drug GMP | Drug discovery company | Review of SOP (GMP) |
| 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 | Investigational Drug GMP consulting |
| 2021 | Domestic | Investigational Drug GMP | Drug discovery company | Investigational Drug GMP consulting |
| 2021 | Domestic | cGMP | Medicine manufacturer | GAP analysis for pharmaceutical manufacturer (cGMP) |
| 2021 | Overseas | GMP | Medicine manufacturer | Detailed design review of pre-filled syringe manufacturing line installation |
| 2021 | Overseas | GMP | Medicine manufacturer | Review of basic design for pre-filled syringe manufacturing line installation |
| 2021 | Overseas | GMP | Medicine manufacturer | Conceptual design review for the construction of a pre-filled syringe manufacturing line |
| 2021 | Domestic | GMP | API manufacturer | GMP consulting for API manufacturer |
| 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 | Medicine manufacturer | Review of SOP (GMP) |
| 2021 | Domestic | GMP | Medicine manufacturer | GMP training |
| 2021 | Domestic | CSV | Medicine manufacturer | CSV consulting (GMP) |
| 2021 | Overseas | Investigational Drug GMP | API manufacturer | Confirmation for CAPA plan (Investigational Drug GMP) |
| 2021 | Domestic | GMP | API manufacturer | Confirmation for CAPA plan (GMP) |
| 2021 | Domestic | GMP | Medicine manufacturer | Evaluation of microbial control (GMP) |
| 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 | Trading company | Training of GMP audit |
| 2021 | Overseas | GMP | Medicine manufacturer | Detailed design support for the construction of an injectable drug manufacturing plant |
| 2021 | Overseas | GMP | Medicine manufacturer | Conceptual design support for construction of an injectable drug manufacturing plant |
| 2021 | Overseas | GMP | Medicine manufacturer | Feasibility study support for the construction of an injection drug manufacturing plant |
| 2021 | Overseas | GMP | Medicine manufacturer | Basic design support for the construction of an injectable drug manufacturing plant |
| 2021 | Domestic | GMP | Medicine manufacturer | Consultation of microbial control (GMP) |
| 2021 | Domestic | cGMP | Pharmaceutical MAH | cGMP consulting for API manufacturer |
| 2021 | Overseas | GMP | Foundation | J-GMP Seminar for Overseas Pharmaceutical Manufacturers |
| 2021 | Overseas | GMP | Medicine manufacturer | Review of layout design (GMP) |
| 2021 | Domestic | GMP | API manufacturer | Proxy audits of starting material manufacturing facilities |
| 2021 | Domestic | GMP | Pharmaceutical MAH | Confirmation of the current status of the PQS at the injectable manufacturing plant（GMP） |
| 2021 | Overseas | Investigational Drug GMP | Pharmaceutical MAH | Confirmation for CAPA plan (Investigational Drug GMP) |
| 2021 | Domestic | GMP | Pharmaceutical MAH | Proxy audits for pharmaceutical manufacturer (GMP) |
| 2021 | Domestic | GMP | Medicine manufacturer | Proxy audits of API Manufacturer (GMP) |
| 2021 | Domestic | GMP | Reagent Manufacturing and Sales Company | Review of analytical procedure validation protocols (GMP) |
| 2021 | Overseas | PMD Act | Pharmaceutical MAH | Consultation for change of Critical Control Parameter |
| 2021 | Overseas | PMD Act | Pharmaceutical MAH | Consultation for Stability Testing |
| 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 | Foundation | Application support for Accredetation of Foreign Manufacturer |
| 2021 | Domestic | GMP | Trading company | Support for preparation of formats for paper-based GMP audits |
| 2021 | Domestic | QMS | Event company | CSA seminar |
| 2021 | Domestic | GMP | Medicine manufacturer | GMP training |
| 2021 | Domestic | GMP | Pharmaceutical MAH | Proxy audit of Pharmaceutical Manufacturer (GMP) |
| 2021 | Domestic | CSV | Medicine manufacturer | Consulting for system implementation |
| 2021 | Domestic | cGMP | API manufacturer | cGMP consulting |
| 2021 | Domestic | GMP | Pharmaceutical MAH | Support for preparation of formats for paper-based GMP audits |
| 2021 | Overseas | GMP | Medicine manufacturer | Consultation for Validation of Packaging |
| 2021 | Domestic | GDP | Certification body | Seminar of GDP |
| 2021 | Domestic | GMP | Trading company | Selling SOPs |
| 2020 | Domestic | cGMP | API manufacturer | FDA Mock inspection (cGMP) |
| 2020 | Domestic | cGMP | API manufacturer | Training/Preparation for FDA Mock inspection (cGMP) |
| 2020 | Domestic | CSV | API manufacturer | CSV support for LIMS installation |
| 2020 | Domestic | GQP | Pharmaceutical MAH | Research for outsourcing contractor |
| 2020 | Overseas | PMD Act | Foundation | Application support for Accredetation of Foreign Manufacturer |
| 2020 | Overseas | Investigational Drug GMP | API manufacturer | Proxy audit of overseas investigational drug API manufacturer (Investigational Drug GMP) |
| 2020 | Domestic | Investigational Drug GMP | Wearhouse company | GMP audit of Pharmaceutical Manufacturer |
| 2020 | Overseas | GMP | Foundation | Seminar of FDF development for Japanese market |
| 2020 | Domestic | PMD Act | Trading company | Support of MF inquiry response from PMDA |
| 2020 | Domestic | GMP | Pharmaceutical MAH | Proxy audit of Pharmaceutical Manufacturer (GMP) |
| 2020 | Domestic | GMP | Trading company | Proxy audit of animal drug manufacturer (GMP) |
| 2020 | Domestic | Investigational Drug GMP | Pharmaceutical MAH | GAP Analysis of investigational drug manufacturer (Investigational Drug GMP) |
| 2020 | Overseas | PMD Act | Foundation | Application support for Accredetation of Foreign Manufacturer |
| 2020 | Overseas | Investigational Drug GMP | API manufacturer | Review of CAPA plan (Investigational Drug GMP) |
| 2020 | Overseas | Investigational Drug GMP | API manufacturer | Confirmation for CAPA plan (Investigational Drug GMP) |
| 2020 | Domestic | GMP | Pharmaceutical MAH | Review of GMP procedures for a pharmaceutical manufacturer |
| 2020 | Domestic | GMP | API manufacturer | GMP consulting for a API manufacturer |
| 2020 | Domestic | cGMP | Pharmaceutical MAH | GMP consulting for investigational drug manufacturer |
| 2020 | Domestic | cGMP | API manufacturer | Review of investigational drug records |
| 2020 | Domestic | cGMP | Pharmaceutical MAH | Construction support of GMP document system (Investigational Drug GMP) |
| 2020 | Domestic | cGMP | Pharmaceutical MAH | Construction support of GMP organization (Investigational Drug GMP) |
| 2020 | Domestic | cGMP | Pharmaceutical MAH | DI/ CSV training (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 | Overseas | Investigational Drug GMP | API manufacturer | Confirmation for CAPA plan (Investigational Drug GMP) |
| 2020 | Overseas | PMD Act | Foundation | Regulation consulting |
| 2020 | Domestic | GMP | Event company | CSV seminar for packaging equipment |
| 2020 | Domestic | PMD Act | Trading company | Regulation consulting |
| 2020 | Overseas | PMD Act | API manufacturer | DMF consultation |
| 2020 | Domestic | cGMP | Pharmaceutical MAH | Review of basic design for the construction of a pharmaceutical manufacturing facility (cGMP) |
| 2020 | Overseas | PMD Act | Foundation | Application support for Accredetation of Foreign Manufacturer |
| Consulting year | Domestic or overseas | Regulation | Category of company | Kind of service |
|---|---|---|---|---|
| 2024 | Domestic | GCTP | Regenerative medicine MAH | Construction support of regenerative medical product systems |
| 2024 | Domestic | GCTP | Regenerative medicine MAH | Formulation of development policy for regenerative medical products |
| 2024 | Domestic | GCTP | Regenerative medicine MAH | Prepare and provide GCTP procedures |
| 2024 | Domestic | GCTP | Regenerative medicine MAH | Prepare and provide GCTP procedures |
| 2024 | Domestic | GCTP | Regenerative medicine MAH | Support for the development of a strategic plan for the management of regenerative medicine products |
| 2024 | Domestic | GCTP | Regenerative medicine MAH | Support for the development of regenerative medicine product management strategies |
| 2024 | Domestic | GCTP | Regenerative medicine MAH | Creation of trilateral guideline list |
| 2024 | Domestic | Others | Regenerative medicine manufacturer | Investigation of legal requirements for conducting clinical trials in Australia |
| 2024 | Domestic | PIC/S GMP | Regenerative medicine manufacturer | GAP analysis of investigational new drug manufacturing facilities（PIC/S GMP Annex2a） |
| 2024 | Domestic | Investigational Drug GMP | Regenerative medicine MAH | Proxy audit of manufacturing plant for investigational product |
| 2024 | Domestic | Others | Regenerative medicine MAH | Training on clinical trial structure |
| 2024 | Domestic | Others | Regenerative medicine MAH | Support for establishment of an organization related to the structure of the clinical trial |
| 2024 | Domestic | Others | Regenerative medicine MAH | Support for preparation of procedures related to the clinical trial system |
| 2022 | Domestic | PMD Act | Regenerative medicine MAH | Investigate regenerative medicine combination product development data |
| 2022 | Domestic | QMS | Regenerative medicine MAH | GAP Analysis (QMS) |
| 2022 | Domestic | Investigational Drug GMP | Educational corporation | Support for creating a template for creating procedure manuals (Investigational Drug GMP) |
| 2022 | Domestic | GCTP | Educational corporation | Documentation Support (GCTP) |
| 2022 | Domestic | PMD Act | Regenerative medicine MAH | Investigation of the current status of regenerative medicine product development data |
| 2022 | Domestic | GMP | Regenerative medicine MAH | Initial GMP training for manufacturing regenerative medicine products |
| 2022 | Domestic | GMP | Regenerative medicine MAH | Support for GMP document development for manufacturing of regenerative medicine products |
| 2022 | Domestic | GMP | Regenerative medicine MAH | Investigation of regenerative medical product manufacturing facilities |
| 2022 | Domestic | GMP | Regenerative medicine MAH | Validation Implementation Status Investigation for Manufacturing and Testing Facilities |
| 2022 | Domestic | Investigational Drug GMP | Educational corporation | Support for development of investigational drug GMP documents for investigator-initiated clinical trials |
| 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 | Basic traning of Investigational Drug GMP |
| 2022 | Domestic | GCP | Regenerative medicine MAH | Support for Risk Assessment |
| 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 investigational drug manufacturing |
| 2022 | Domestic | GCP | Regenerative medicine MAH | Support for compiling data to determine manufacturing process |
| 2022 | Domestic | GCP | Regenerative medicine MAH | Training for Drug Product Development |
| 2022 | Domestic | Investigational Drug GMP | Regenerative medicine MAH | Support for Test Method Validation |
| 2022 | Domestic | GCP | Regenerative medicine MAH | Support for compiling data to determine test criteria and methods |
| 2022 | Domestic | Investigational Drug GMP | Regenerative medicine MAH | Support for determination of in-process testing and quality test criteria |
| 2022 | Domestic | GCP | Regenerative medicine MAH | Support for compilation of development data |
| 2022 | Domestic | Investigational Drug GMP | Educational corporation | Review of investigational drug manufacturing docymentented manufactuuring orders for investigator-initiated clinical trials |
| 2022 | Domestic | GCTP | Regenerative medicine MAH | Investigation into the current status of quality assurance for shipments of regenerative medicine products |
| 2022 | Domestic | GCP | Regenerative medicine MAH | Investigation of the current status of regenerative medicine product development data |
| 2022 | Domestic | GCP | Regenerative medicine MAH | Technical training on development |
| 2022 | Domestic | GMP | Regenerative medicine MAH | Technical training on GMP |
| 2022 | Domestic | GCTP | Regenerative medicine MAH | Record review for shipments of regenerative medicine products |
| 2022 | Domestic | GMP | Regenerative medicine MAH | Support for improvement of manufacturing facilities for regenerative medical products |
| 2022 | Domestic | GMP | Regenerative medicine MAH | Organize requirements and prepare UR for factory build-out |
| 2022 | Domestic | GMP | Regenerative medicine MAH | Review of detailed design 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 | Advise of PQ for factory build out |
| 2022 | Domestic | GMP | Regenerative medicine MAH | IQ/OQ documentation for factory build out |
| 2022 | Domestic | GMP | Regenerative medicine MAH | Preparation of DQ for factory build out |
| 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 | GCTP | Regenerative medicine manufacturer | Support in organizing manufacturing and test processes for CPC construction |
| 2022 | Domestic | GCTP | Regenerative medicine manufacturer | Detailed design support for CPC construction |
| 2022 | Domestic | GCTP | Regenerative medicine manufacturer | Basic design support for CPC construction |
| 2022 | Domestic | GCTP | Regenerative medicine manufacturer | Basic planning support for CPC construction |
| 2022 | Domestic | Others | Drug discovery company | Support for licensing out of pharmaceutical products |
| 2021 | Domestic | GCTP | Regenerative medicine MAH | GCTP consulting |
| 2021 | Domestic | Investigational Drug GMP | Educational corporation | SOP's and record review for regenerative medicine products |
| 2021 | Domestic | GCTP | Regenerative medicine MAH | Proxy audits of regenerative medicine products Manufacturer (GCTP) |
| 2021 | Domestic | QSR | Medical device MAH | Investigation of regenerative medicine combination product development data for export to the U.S. |
| 2021 | Domestic | Others | Medical device MAH | Investigation of development data for regenerative medicine combination products |
| 2021 | Domestic | QSR | Medical device MAH | GAP analysis in the development of regenerative medicine combination products |
| 2021 | Domestic | GCTP | Educational corporation | Support for revision of SOPs (GCTP) |
| 2020 | Domestic | GCTP | Regenerative medicine MAH | Review for stabiity study report of regenerative medicine (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 | Current situation analysis/consultation 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 | 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 | GMP/ GCTP training |
| 2020 | Domestic | GCTP | Educational corporation | Making SOPs for regenarative medicine's factory (GCTP) |
| 2020 | Domestic | GCTP | Educational corporation | GCTP consulting |
| 2020 | Domestic | GCTP | Regenerative medicine MAH | GAP analysis for a regenerative medicine manufacturer (GCTP) |
| 2020 | Domestic | GCTP | Regenerative medicine MAH | GCTP training |
| Consulting year | Domestic or overseas | Regulation | Category of company | Kind of service |
|---|---|---|---|---|
| 2024 | Domestic | QMS | Medical device MAH | Proxy audit support for medical device warehouses |
| 2024 | Domestic | QMS | Medical device MAH | Training support for SOPs related to QMS |
| 2024 | Domestic | QMS | Medical device MAH | Revision of risk management SOP's |
| 2024 | Domestic | QMS | Medical device MAH | Training for risk management |
| 2024 | Domestic | QMS | Medical device MAH | Support for creating Usability Engineering Procedures |
| 2023 | Domestic | QMS | Medical device MAH | Consultation for vaccine filling facilities |
| 2023 | Domestic | QMS | Medical device MAH | Self-inspection of medical device manufacturers (QMS) |
| 2023 | Domestic | CSV | Medical device manufacturer | Support for creation of CSV-related business standards |
| 2023 | Domestic | PMD Act | Medical device MAH | Support for preparation of application for patical changes documents |
| 2023 | Domestic | QMS | Medical device MAH | Consultation for Revised QMS Regulations |
| 2023 | Domestic | QMS | Medical device MAH | Self-inspection of medical device MAH |
| 2023 | Domestic | QMS | Medical device MAH | Review of revised procedures regarding QMS |
| 2023 | Domestic | QMS | Medical device MAH | On-site consulting for QA operations |
| 2023 | Domestic | QMS | Medical device MAH | Support for QMS document review |
| 2023 | Domestic | QMS | Pharmaceutical MAH | Preparation support for medical device MAH update audits |
| 2023 | Domestic | Others | Medical device MAH | Consultation for GLP |
| 2022 | Domestic | CSV | Medical device MAH | Prepared validation report 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 | 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 | PQ plan drafting 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 | Create and review IQ reports for warehouse management system installation |
| 2022 | Domestic | QMS | Cosmetic MAH | Proxy audit of medical device storage contractor (QMS) |
| 2022 | Domestic | CSV | Medical device MAH | Validation plan drafting for QMS management system upgrade |
| 2022 | Domestic | CSV | Medical device MAH | Validation report preparation 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 | PQ documentation and PQ implementation 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 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 | Validation report preparation 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 | PQ documentation and PQ implementation 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 manufacturer | Support for policy discussions for CSV document development |
| 2022 | Domestic | CSV | Medical device manufacturer | Support for CSV document development |
| 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 | QMS | Medical device MAH | Support for QMS improvement |
| 2022 | Domestic | CSV | Medical device manufacturer | Support for SOP creation related to CSV |
| 2021 | Domestic | CSV | Medical device MAH | Project promotion support for warehouse management system installation |
| 2021 | Domestic | CSV | Medical device MAH | CSV consultation for warehouse management system installation |
| 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 | QMS | Medical device MAH | Explanation of QMS overview |
| 2021 | Domestic | CSV | Medical device MAH | Verification of ERP system installation |
| 2021 | Domestic | CSV | Medical device MAH | Review of vendor specifications for ERP system installation |
| 2021 | Domestic | QMS | Medical device MAH | Construction support of QMS system |
| 2021 | Domestic | QMS | Medical device MAH | Construction support of QMS system |
| 2021 | Domestic | QMS | Medical device MAH | Support for QMS Organization Establishment |
| 2021 | Domestic | CSV | Medical device MAH | CSV consultation for warehouse management system installation |
| 2021 | Domestic | QMS | Medical device MAH | Review of layout design (QMS) |
| 2021 | Domestic | CSV | Medical device MAH | CSV verification for ERP installation |
| 2020 | Domestic | CSV | Medical device MAH | CSV support for ERP system installation (verification) |
| 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 consulting for ERP system installation |
| 2020 | Domestic | QMS | Medical device MAH | Special adviser of medical devices company (QMS) |
#REF!
| Consulting year | Domestic or overseas | Regulation | Category of company | Kind of service |
|---|---|---|---|---|
| 2024 | Domestic | cGMP | Cosmetic MAH | GAP analysis of a cosmetics factory(cGMP) |
| 2024 | Domestic | cGMP | Cosmetic MAH | GAP analysis of a cosmetics factory warehouse(cGMP) |
| 2024 | Domestic | EFfCI | Cosmetic ingredient manufacuturer | GAP analysis of a cosmetics factory(ISO9001・EFfCI) |
| 2024 | Domestic | Cosmetic GMP | Cosmetic MAH | GAP analysis of a cosmetics factory(ISO22716) |
| 2024 | Domestic | cGMP | Cosmetic ingredient manufacuturer | GMP Elementary Training Support |
| 2024 | Domestic | EFfCI | Cosmetic ingredient manufacuturer | GAP Analysis of Cosmetic Ingredient Manufacturing Facility |
| 2024 | Domestic | cGMP | Cosmetic MAH | GAP analysis of domestic cosmetics manufacturing facilities（cGMP） |
| 2024 | Domestic | EFfCI | Cosmetic ingredient manufacuturer | Support for developing a CSV implementation plan for a cosmetics raw materials factory |
| 2024 | Domestic | EFfCI | Cosmetic ingredient manufacuturer | Support for the development of a structural facility improvement plan for a cosmetics raw materials factory |
| 2024 | Domestic | Cosmetic GMP | Cosmetic MAH | GAP analysis of a cosmetics factory(ISO22716) |
| 2023 | Domestic | cGMP | Cosmetic ingredient manufacuturer | GAP analysis for API manufacturer (cGMP) |
| 2023 | Domestic | cGMP | Cosmetic ingredient manufacuturer | GMP trainning for API manufacturer |
| 2023 | Domestic | Cosmetic GMP | Quasi-drug MAH | Proxy audit of Cosmetics Manufacturer (Cosmetic GMP) |
| 2023 | Domestic | cGMP | Cosmetic ingredient manufacuturer | GAP analysis for API manufacturer (cGMP) |
| 2023 | Domestic | cGMP | Cosmetic ingredient manufacuturer | Support for preparation for FDA inspection |
| 2023 | Domestic | Others | Cosmetic MAH | Consultation on OTC drugs for the U.S. |
| 2023 | Domestic | cGMP | Cosmetic ingredient manufacuturer | Support for accompanying and logistics for FDA inspection |
| 2023 | Domestic | cGMP | Cosmetic ingredient manufacuturer | Support for response to FDA findings (Form 483) |
| 2023 | Domestic | cGMP | Cosmetic ingredient manufacuturer | FDA Inspection Interpreter (Japanese/English) |
| 2022 | Domestic | EFfCI | Cosmetic ingredient manufacuturer | GAP Analysis of Cosmetic Ingredient Manufacturing Plant (EFfCI GMP) |
| 2022 | Domestic | Cosmetic GMP | Cosmetic MAH | Proxy audit（Cosmetic GMP） |
| 2022 | Domestic | PMD Act | Medical device MAH | Investigation to apply for permission to use colorants in Japan |
| 2022 | Domestic | EFfCI | Cosmetic ingredient manufacuturer | EFfCI GMP Improvement Consulting for Cosmetics Manufacturer |
| 2022 | Domestic | cGMP | Cosmetic ingredient manufacuturer | cGMP training for API manufacturer |
| 2022 | Domestic | cGMP | Cosmetic ingredient manufacuturer | cGMP consulting for API manufacturer |
| 2022 | Domestic | Cosmetic GMP | Cosmetic MAH | Proxy audit of cosmetics storage contractor（Cosmetic GMP） |
| 2022 | Domestic | Cosmetic GMP | Material manufacturer | Proxy audit of cosmetics storage contractor（Cosmetic GMP） |
| 2022 | Domestic | EFfCI | Cosmetic ingredient manufacuturer | Support for review of proposed product filling room modifications |
| 2021 | Domestic | cGMP | Cosmetic ingredient manufacuturer | Confirmation of improvement status (cGMP) |
| 2021 | Domestic | cGMP | Cosmetic ingredient manufacuturer | Consulting on item addition (cGMP) |
| 2021 | Domestic | cGMP | Cosmetic ingredient manufacuturer | Advice for CAPA plan (cGMP) |
| 2021 | Domestic | cGMP | Cosmetic ingredient manufacuturer | Review of CAPA plan (cGMP) |
| 2021 | Domestic | cGMP | Cosmetic ingredient manufacuturer | CSV consulting (cGMP) |
| 2021 | Domestic | cGMP | Cosmetic ingredient manufacuturer | cGMP training |
| 2021 | Domestic | Cosmetic GMP | Cosmetic manufacturer | GAP Analysis (Cosmetic GMP) |
| 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) |
| 2020 | Domestic | cGMP | Cosmetic ingredient manufacuturer | Making basic engineering design and masterplan of factory construction (cGMP) |
| 2020 | Domestic | Cosmetic GMP | Cosmetic manufacturer | GAP Analysis of Cosmetics Manufacturer (Cosmetic GMP) |
| 2020 | Domestic | cGMP | Cosmetic ingredient manufacuturer | FDA Mock inspection of API Manufacturer (cGMP) |
| 2020 | Domestic | EFfCI | Cosmetic ingredient manufacuturer | GAP Analysis of Cosmetic Ingredient Manufacturer (EFfCI GMP) |
| Consulting year | Domestic or overseas | Regulation | Category of company | Kind of service |
|---|---|---|---|---|
| 2024 | Domestic | Others | Material manufacturer | GAP analysis of documents for ISO 15378 certification |
| 2024 | Domestic | GMP | Material manufacturer | Support for basic planning of buildings and building facilities |
| 2024 | Domestic | GMP | Material manufacturer | Support for installation of water facilities |
| 2024 | Domestic | CSV | Material manufacturer | Support for business-related IT system studies |
| 2024 | Domestic | Others | Material manufacturer | Construction of ISO 15378 related documents |
| 2024 | Domestic | GMP | Material manufacturer | Basic plan and basic design development for additional lines |
| 2024 | Domestic | GMP | Material manufacturer | Review of specifications for water facilities |
| 2024 | Domestic | GMP | Material manufacturer | Support for validation of production facilities (equipment listing and VMP Creation) |
| 2024 | Domestic | CSV | Material manufacturer | Confirmation of current system specifications |
| 2024 | Domestic | CSV | Material manufacturer | Study of systems for additional lines |
| 2024 | Domestic | GMP | Equipment sales company | Training support for regulations related to pharmaceutical manufacturing equipment |
| 2024 | Domestic | Others | Material manufacturer | Documentation support for ISO15378 |
| 2024 | Domestic | CSV | Material manufacturer | Support for CSV (PQ) of existing IT systems |
| 2024 | Domestic | GMP | Material manufacturer | PQ support for existing production facilities |
| 2024 | Domestic | GMP | Material manufacturer | Design support for buildings and building equipment for factory construction |
| 2024 | Domestic | GMP | Material manufacturer | VMP and URS creation support for building facilities in factory construction |
| 2024 | Domestic | GMP | Material manufacturer | URS and DQ support for introduction of water facilities for production |
| 2024 | Domestic | GMP | Material manufacturer | URS and PQ support for production facilities in factory construction |
| 2024 | Domestic | CSV | Material manufacturer | Vendor selection support for IT system implementation |
| 2023 | Domestic | Others | Material manufacturer | Review of product specifications |
| 2023 | Domestic | GMP | Material manufacturer | Concept design and planning support for new facility construction |
| 2022 | Domestic | GMP | Material manufacturer | Support for preliminary study of packaging specifications |
| 2022 | Domestic | GMP | Material manufacturer | Support for preliminary study of manufacturing process |
| 2022 | Domestic | GMP | Material manufacturer | Support for preliminary study of equipment and facilities for new factory |
| 2022 | Domestic | GMP | Material manufacturer | Creation of roadmap for validation (GMP) |
| 2022 | Domestic | GMP | Material manufacturer | Investigation of the current status of validation |
| 2022 | Domestic | GMP | Material manufacturer | Provide a validation procedure template |
| 2022 | Domestic | GMP | Material manufacturer | GAP Analysis for Material Manufacturing Plants (GMP) |
| 2022 | Domestic | GMP | Material manufacturer | Create and review master batch records |
| 2022 | Domestic | GMP | Material manufacturer | Creation of Validation Master Plan |
| 2022 | Domestic | GMP | Material manufacturer | Review of PV Plan/Report |
| 2022 | Domestic | GMP | Material manufacturer | Review of PQ Plan/Report |
| 2022 | Domestic | GMP | Material manufacturer | Review of IOQ Plan/Report |
| 2021 | Domestic | GMP | Material manufacturer | Consultation for Construction of Rubber Plug Manufacturing Plant |
| 2021 | Domestic | GMP | Material manufacturer | GMP training |
| 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 | Support for preliminary study of equipment and facilities for new factory |
| 2021 | Domestic | GMP | Material manufacturer | Investigations of the current plant for the construction of a new plant |
| Consulting year | Domestic or overseas | Regulation | Category of company | Kind of service |
|---|---|---|---|---|
| 2024 | Domestic | GMP | Construction company | Validation Document Review |
| 2024 | Domestic | GMP | Architectural Design Company | GMP training for pharmaceutical manufacturing plant construction |
| 2024 | Domestic | GMP | Construction company | Training about URS |
| 2024 | Domestic | GMP | Construction company | Training on Impact Assessment |
| 2024 | Domestic | GMP | Construction company | Training for CSV |
| 2022 | Domestic | GMP | Construction company | Engineering support for warehouse construction |
| 2021 | Domestic | GMP | Construction company | Competition support as an inner consultant (GMP) |
| 2021 | Domestic | GMP | Construction company | Specification review and meetings regarding warehouse construction |
| 2021 | Domestic | GMP | Construction company | Design review and meeting regarding warehouse construction (GMP) |
| 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 | Detailed design support for the construction of an injectable drug manufacturing plant |
| 2021 | Domestic | GMP | Construction company | Basic design support for the construction of an injectable drug manufacturing plant |
| 2020 | Domestic | GMP | Construction company | Special adviser of construction company for getting construction project in pharmaceutical industry (GMP) |
| Consulting year | Domestic or overseas | Regulation | Category of company | Kind of service |
|---|---|---|---|---|
| 2024 | Domestic | CSV | Equipment sales company | Training for CSV |
| 2024 | Domestic | CSV | Equipment sales company | Consultation for CSV |
| 2024 | Domestic | CSV | Trading company | DI support for development systems |
| 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 |
| 2023 | Domestic | GMP | Equipment sales company | Training for equipment manufacturers about validation |
| 2023 | Domestic | CSV | System company | Training for Validation/CSV implementation |
| 2022 | Domestic | QMS | Equipment sales company | Support for consultation on validation of imaging inspection equipment |
| 2022 | Domestic | QMS | Equipment sales company | Validation training for equipment suppliers |
| 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 creation of validation documentation for imaging inspection equipment (DQ, IQ, OQ) |
| 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 |
| 2021 | Domestic | QMS | Equipment sales company | Validation training for equipment manufacturers (QMS) |
| 2021 | Domestic | cGMP | Equipment sales company | Validation training for equipment manufacturers (cGMP) |
| 2021 | Domestic | GMP | Equipment sales company | Validation training for equipment suppliers |
| Consulting year | Domestic or overseas | Regulation | Category of company | Kind of service |
|---|---|---|---|---|
| 2024 | Domestic | GMP | System company | Training for CSV |
| 2024 | Domestic | GMP | Public-service corporation | Seminar on Pharmaceutical Quality System |
| 2024 | Domestic | QMS | Logistics company | Web consultation on obtaining a medical device manufacturing license, etc. |
| 2024 | Domestic | GMP | Pharmaceutical manufacturing component manufacturer | Support for improvement plans for findings from audits |
| 2024 | Domestic | GMP | Pharmaceutical manufacturing component manufacturer | GAP analysis of manufacturing facilities for Biopharmaceutical Manufacturing Components (GMP) |
| 2023 | Domestic | GMP | Medicine manufacturer | Proxy audits of pharmaceutical manufacture (GMP) |
| 2023 | Domestic | GMP | Pharmaceutical MAH | Creation of audit checklist (GMP) |
| 2023 | Domestic | CSV | System company | CSV support for production management systems |
| 2023 | Domestic | GMP | Medicine manufacturer | Proxy audits of pharmaceutical manufacture (GMP) |
| 2023 | Domestic | GMP | Medicine manufacturer | Proxy audits of pharmaceutical manufacture (GMP) |
| 2023 | Domestic | GQP | Medicine manufacturer | Proxy audits of pharmaceutical MAH (GQP) |
| 2023 | Domestic | GCP | Medicine manufacturer | Proxy audits of pharmaceutical development facility (GCP) |
| 2022 | Domestic | CSV | Clinical laboratory testing company | CSV document review for maintenance management system installation |
| 2022 | Domestic | CSV | Clinical laboratory testing company | CSV document drafting for installation of maintenance management system |
| 2022 | Domestic | GMP | Event company | DI Seminar |
| 2022 | Domestic | GMP | Analysis company | GAP analysis of laboratory (GMP) |
| 2021 | Domestic | CSV | Clinical laboratory testing company | Creation of a validation plan for the 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 | Validation report review 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 | 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 |
| 2020 | Domestic | CSV | Clinical laboratory testing company | CSV documentation support for installation of a scratch system |
| 2020 | Domestic | CSV | Clinical laboratory testing company | CSV consulting for installation of a scratch system |
| 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 how-to register as quasi-drug in Japan against medicated toothpaste from overseas country |
| 2020 | Overseas | PMD Act | Cosmetic MAH | Research of claim/advertisement risk in Japan against medicated toothpasete from overseas country |
| 2020 | Overseas | PMD Act | Cosmetic MAH | Research of regulation in Japan against medicated toothpaste from overseas country |
| 2020 | Domestic | PMD Act | Quasi-drug MAH | Consultation for application of quasi-drug |