Case Study 48: GMP Quality Audit of CMO in Japan
The client is a European pharmaceutical company with no presence in Japanese market but has to conduct local clinical studies with PMDA.
Case Study 12: Regulatory Strategy and MAH Services in Japan
The Client had developed medical devices intended for spine fusion (Class III devices) and related surgical instruments used for their implementation (Class I devices).
Case Study 16: Support for Change of In-Country Caretaker (ICC) in Japan for a European API company Client Situation
The client was a US Based CRO who is managing Clinical Data for a multinational pharmaceutical company, that is conducting clinical studies in USA and Japan.
Case Study 32 : Registration of Class III Medical Devices (Software) with PMDA in Japan
Client did not have presence in Japan and no prior experience with PMDA, Client selected GRP as a partner to help it succeed in Japan.
Case Study 30 : Registration of API DMF and In-Country Care Taker Services in Japan
The Client is a European manufacturer of API and wanted to register the DMF of one of its APIs in Japan before selling its API to a drug manufacturer in Japan.
Case Study 22 : Regulatory, Clinical & Commercial Support for IVD Company in Japan
The Client is US in-vitro medical device company that wanted to register its IVD in Japan that is Class III device. There was no similar device in Japan, the conduct of a local clinical study was requested by PMDA.