To offer the best DMF, the best AFM and the best customer(s) in Japan for the product.
Exchanging opinions until we understand the information provided by the client.
Sharing all the events and inquiries of PMDA relating to the product with the client, for the right decision.
Monitoring the regulations and the market for the product in Japan, the finding is also being shared with the client every time.
Pharma Partners staff are experts experienced for many years at Production, QC, Regulatory, Licensing and Business development in pharmaceutical industries.
The motto of Pharma Partners is “Do in good faith, trust people and be trusted”.
Pharma Partners offers;
- Regulatory Affairs Consulting Service
- Business Development Consulting Service
- Other Services
- Preparation of regulatory strategy
- Support for the various consultations with PMDA
- Preparation, registration and maintenance of the Drug Master File (DMF)
- Preparation and support for the GMP Compliance Inspection performed by PMDA
- Preparation, obtaining registration and maintenance of Accreditation of Foreign Manufacturer (AFM)
When a product (drug product or API, in either case) is imported and marketed in Japan, the manufacturing site (plant) is required to have the Accreditation of Foreign Manufacturer (AFM) Certificate issued by the Authority (MHLW*) and also it is required that the DMF of API is registered at the Authority (PMDA) in order to keep the manufacturing know-how in confidential to the customers. The DMF is reviewed when the drug product referring the DMF is reviewed for the approval by PMDA as same as USA and Europe. (The DMF in Japan, however, is a unique DMF among DMFs in USA and Europe.)
MHLW*: Ministry of Health, Labour and Welfare
- Pharma Partners can prepare the Japanese DMF, which is advantageous to its client and meets the requirement of PMDA. Pharma Partners can respond properly to the inquiries on DMF from PMDA and support the GMP Inspection performed by PMDA in both cases of on-site inspection and document-based inspection.
- Pharma Partners communicates with PMDA quite often and closely by telephone, fax, and has a meeting if it is required.
- The PMDA's inquiries and all communication with them are translated into English and reported to clients in a timely manner.
- Regarding AFM, Pharma Partners deals with it as same as DMF.
- Pharma Partners can work as a regulatory team, or a partner in Japan of the client.
- Conducting Market Research / Survey
- Preparation of Business Strategy
- Partnering (Alliance, Acquisition)
- Pharma Partners can respond to questions and requests raised by clients, who will introduce their product(s) into Japan. Pharma Partners can support the client to prepare the most suitable development plan for its product, and introduce or find out the potential end user(s) and customers to the client.
- Establishment of the Subsidiary in Japan
- Pharma Partners shall provide clients with services other than business development and regulatory issues through its own broad human network.