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J-DMF & AFM

Submission of J-DMF and Application of AFM

The staff with abundant experience in the field of CMC takes charge of preparation and submission for J-DMF and application for AFM(Accreditation of Foreign Manufacture). RPM had experiences for submission and application of a lot of J-DMFs and AFMs. Moreover high quality documents are prepared with the thorough and accurate checking by staff before the submission and/or the application. During examination by PMDA, the staff takes charge of inquiries for the content of J-DMF and GMP compliance inspection. After approval, the staff supports change control (Partial change application or Minor change notification) if exists.

    Services related to pharmaceutical regulatory affairs

Procedure

1) AFM

Client prepares the following documents to send them to RPM.

■ Medical certificate or self-declaration of the responsible person in plant

■ Personal history of the responsible person in plant

■ Simple site map & Site master plan of plant

■ Floor plans

■ Equipments for manufacturing

■ Testing facilities used

■ others

 

→RPM submits the above documents to PMDA.

   If no fault exists, PMDA will issue the Accreditation Certificate.

 

2) J-DMF

■ Client sends CTD module 3 (restricted part) to RPM

■ The staff prepares J-DMF based on CTD module 3 while communicating with client

■ Client has CEO sign in the cover letter which RPM sends to client, to return the original copy to RPM

■ After submission, PMDA sends inquiries to RPM while RPM translates them into English to send them to client

■ Client returns the answers to RPM while RPM translates them into Japanese to send them to PMDA

■ After approval, the staff supports change control of plant (if exists)

 

 Our strength is...

▶Our professionals and specialists have extensive experience in all types of procedures and registrations in Japan.
 
An experienced support staff from a pharmaceutical manufacturer makes a final check on the product created by the advisor, resulting in a higher quality product.
 
▶Ability to provide a high quality documents through QC service.
Our QC service provides a high quality documents by specialists with the thorough and accurate check based on the scientific evidence. Not only in the field of pharmaceutical products, but also we handle the wild range of field such as quasi-drug, medical device, pesticide, veterinary drug, cosmetics, and functional foods.