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.
Company Situation Client’s IVD product was classified as Class III in Japan and required a clinical trial to be done locally. There was no similar
EU-based manufacturer of Class II medical devices with a CE mark seeks GRP as partner in USA to support the registration process US FDA via 510(k) pathway.
US based Tele-Densitry client seeking partner for global access and regulatory strategy for getting registration of cosmetic product in EU.