The Client was in the process of commercializing its new developed oral fluid based covid-19 rapid antigen test in global markets. Japan was one of the key markets for the client for strategic expansion. However, they did not have a regional presence nor any prior experience with PMDA. Considering stringent regulations in Japan and requirement for clinical trials, Client sought a strategic partner who could own the registration of their IVD device in Japan through the entire development phase and marketing.
GRP has successfully helped global corporations obtain approvals for their Covid 19 related IVD, pharmaceutical and vaccine products. Using GRP Japan’s 30+ years of experience with PMDA, In-vitro diagnostics products and insights from Covid 19 tests, GRP stepped up as integrated partner for client to help them navigate through the development and registration phases of their product in Japan.glo