Global Regulatory Partners GK located in Tokyo Japan, is the In Country Caretaker (ICC) for Novavax. GRP’s role, as ICC, is to represent, develop regulatory strategy, prepare documentation, and communicate with PMDA (Pharmaceuticals and Medical Devices Agency) on behalf of Novavax.
“We are thrilled and congratulate Novavax for successful approval of their mRNA based COVID vaccine by PMDA. This is a significant milestone in GRP Japan’s journey and a testimony to our commitment to our clients’ success in Asia”
GRP Japan’s team, using their 30+ years of diplomatic experience with PMDA, have spent thousands of hours to meet the critical deadlines from PMDA. GRP has worked closely with Novavax’ European team to meet inquiry timelines sometimes as short as 24 hours. The approval was received on 19th April following over five months of communication back and forth with PMDA.
“We truly appreciate all of GRP’s help and guidance with this program, and their diplomacy with the PMDA on behalf of Novavax”
The vaccine from Novavax is expected to be available in Japan in late May 2022.
About Global Regulatory Partners GK (GRP)
GRP is a global integrated regulatory, quality, clinical and safety strategy consulting and services company headquartered in Massachusetts, USA (United States of America) with global offices in Japan, China, South Korea, Brazil, and Mexico. GRP has helped over 400 pharmaceutical, biotech and medical device companies to successfully obtain approvals in global markets for DMFs (Drug Master Files), New Drug Applications (NDA), Abbreviated NDAs, Investigational New Drugs (IND) for Novel Molecules, Generics, Biologics, Biosimilars and Medical Devices.