CMC Regulatory Affairs

CMC Regulatory Affairs

CMC Regulatory

On the export/import of pharmaceutical products, Accreditation of Foreign Manufcaturer (AFM/FMA) and J-DMF Registration are to be required according to the Japanese Pharmaceutical Medical Device Law.

We, Pharma Parners, provide expertized services for these registration as a In-Country Caretaker (ICC) and continuously maintenance jobs of COC which is also the essential parts of the requirements.

We also support the GMP Compliance Inspection matters.

Accreditation of Foreign Manufacturer (AFM/FMA):
On exporting the pharmaceutical products to Japan AFM/FMA is required.
We prepare the documents for it by receiving the site master file from you
and apply it to PMDA/MHLW.
AFM/FMA would be issued after the inquiries/answer for which we play our roles by the communication with you and PMDA/MHLW.
- Accreditation Process -
Foreign Manufacturer
Site master File(Floor plan, Facilities, etc)
In-Country Caretaker (ICC, Pharma Partners)
Application document preparation of AFM/FMA
Application to PMDA/MHLW
Registration of MF/J-DMF:
We, as ICC, play our roles J-DMF preparation and register it by the name of manufacturer. The process until the registration would be by the communication among you, PMDA and us by English & Japanese.
Our staffs are fully experienced throughout the jobs before.
- Registration Process -
Foreign Manufacturer
CTD Module3
In-Country Caretaker (ICC, Pharma Partners)
MF/J-DMF preparation)
Application to PMDA
GMP Compliance Inspection (for MA Approval and Periodical):
We support the GMP Inspection matters by the preparation of documents, application and/or on-site.
Total supports will be served with the knowledges about those requirements.