CMC Regulatory Affairs
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.
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.
Our staffs are fully experienced throughout the jobs before.
Total supports will be served with the knowledges about those requirements.