Client is a European pharmaceutical manufacturer that intended to market its products in Japan. However, the client didn’t have any presence in Japan with no prior experience of the market. The client was looking for an experienced regulatory and market access partner with regional presence in Japan to be able to act as their Marketing Authorization Holder and represent them to the PMDA.
Global Regulatory Partners, GK based in Tokyo, Japan has decades of experience in successfully commercializing pharmaceutical products on behalf of their clients. GRP’s seasoned regulatory experts provided the Client with timely strategy and execution of project to obtain the commercial license using following steps,