Case Study 14 : Support for Change of In-Country Caretaker (ICC) in Japan for a European API company Client Situation

Company Situation

Client currently had an ICC in Japan and wanted to change it to another company with expertise in regulatory space. They reached out to GRP to act as their ICC and change from the current ICC to GRP.

GRP Solution

GRP has worked with many API manufacturing companies as their ICC in Japan. Over the period of time, GRP has helped clients identify overcome the multiple challenges in registering their API with PMDA and interacting with local drug manufacturing that our Clients’ have often faced issues related to transparency, regulatory expertise and efficiency in project management with their existing distributors or ICC partners. GRP has filled this gap and stood out partner of choice for Clients using a decade of experience, understanding of Japanese nuances and local teams.

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Aerial view of Tokyo cityscape with Fuji mountain in Japan, Tokyo

Japan's PMDA

In Japan, The Pharmaceuticals and Medical Devices Agency (PMDA) is the government organization in charge of reviewing drugs and medical devices, overseeing post-market safety, and providing relief for adverse health effects. The PMDA operates under the Ministry of Health, Labor, and Welfare (MHLW) .These two government organization both handle a wide range of activities, from approval reviews to post-market surveillance.