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JAPANESE

Support Submission of J-DMF and Application of AFM

Proposal Number : 1169290       Provide business supports
Date Date of Registration : Oct 08, 2020
Date of Revision : Oct 19, 2020
Country / AreaTokyo, Japan 
Proposal Category 0403 Pharmaceutical materials, pharmaceutical preparation(including biochemicals)
4700 Trading businesses
0404 Fertilizers, pesticides
Target Country / Area All Countries / Areas

*Attention: JETRO shall not take any responsibility for the contents provided by users. Please take note of the fact that JETRO leaves the exactness and reliability of the contents to users' judgment.

Detail Description

Support Submission of J-DMF and Application of AFM

<< DESCRIPTION >>
We support submission of J-DMF and application of AFM

1) AFM
1.Client prepares the following documents to send them to us.
2.Medical certificate or self-declaration of the responsible person in plant
3.Personal history of the responsible person in plant
4.Simple site map & Site master plan of plant
5.Floor plans
6.Equipments for manufacturing
7.Testing facilities used
8.others

>We submit the above documents to PMDA.
If no fault exists, PMDA will issue the Accreditation Certificate.

2) J-DMF
1.Client sends CTD module 3 (restricted part) to us.
2.The staff prepares J-DMF based on CTD module 3 while communicating with client
3.Client has CEO sign in the cover letter which we send to client, to return the original copy to us.
4.After submission, PMDA sends inquiries to us while we translate them into English to send them to client
5.Client returns the answers to us while we translates them into Japanese to send them to PMDA
6.After approval, the staff supports change control of plant (if exists)

** Features of Your Service
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). We 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.

** Examples of Fees
Please contact us.

** Business Results
We have many achievements at trading companies and drug substance manufacturers related to pharmaceuticals and veterinary drugs.

User Info
Proposals Registered by this Corporation and User    (2 total matches)

Support Development of Pharmaceuticals/Medical Devices

Provide business supports

Tokyo, Japan

Oct 08, 2020 RegistrationOct 08, 2020 Revision

Total Sum of CONTACT Received : 0

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