Case Study 122: Application for New Foreign Manufacturer Accreditation (FMA/FMR)

Company Situation

A US based pharmaceutical company specialized in the development and manufacture of intermediates used in the formulation of vaccines wanted to ship urgently some of its products to a drug manufacturer in Japan for vaccines manufacture. However, due to the fact that the company has never shipped its products to Japan, it was requested to get its manufacturing site accredited by PMDA and receive an FMA certificate before making any shipment to Japanese market.

As the company has no experience with FMA process, it started looking for a local partner who has experience in the preparation and submission of foreign manufacturer accreditation (FMA) to PMDA, that can help them with that process.

GRP Solution

GRP acted as a local representative to the company in Japan ( ICC) and provided the following services:

Want to be updated on the Latest Regulatory Information

Follow GRP on Social Media !