Regulatory Affairs Support
We provide operational support for regulatory involvement in each stage of pharmaceutical and medical device development. The development of pharmaceuticals and medical devices is conducted with the objective of applying for approval to obtain marketing authorization in the final market. PPBIZ performs regulatory affairs not only in-house, but also in cooperation with local regulatory affairs consulting firms overseas. PPBIZ also conducts its own regulatory research and assists in the preparation of various application documents. PPBIZ also handles applications for AFM (Authorization of Foreign Manufacturer), MF (Manufacturer's File), and related inquiries, as well as in-country caretaker services.
Support for Regulatory Strategy
We provide support for the formulation of regulatory strategies in the development of pharmaceutical products.
- Establishment of pharmaceutical affairs strategies related to the formulation of development plans
- Research on pharmaceutical regulations related to drug development
- Research on existing therapeutic drugs for the target disease of the drug development
- Support for various application procedures
- Preparation of various application documents (see Medical Writing below)
Medical Writing
We support the preparation of various documents required for applications for approval of pharmaceutical products.
- Investigator’s brochure / Investigational medicinal drug product summaries / investigational product summaries / investigational device summaries
- Protocol and related documents
- Consent Explanatory Document
- PMDA consultation documents
- Draft clinical trial summary report
- Preparation of documents related to application
- CTD (Clinical Technical Document)
- STED (Summary Technical Documentation)
- Compilation of eCTD
- Response to inquiries from regulatory authorities
- Masking (CTD, review report)
Application for MF (Master File)
PPBIZ acts as an In-Country Caretaker (ICC) on behalf of overseas API manufacturers.
PPBIZ acts as an In-Country Caretaker (ICC) for overseas API manufacturers and applies for AFM (Authorization of Foreign Manufacturer) on their behalf in Japan.
PPBIZ acts as an In-Country Caretaker PPBIZ (ICC) for APIs applying for MF and registration of their product manufacturing methods, etc. PPBIZ also assists in negotiations with the authorities, smooth communication of information, and support for quality and other approval reviews.