C-reactive Protein Test Reagent Received Registration Six Months Sooner Than Market Standard
The challenge: Client wants to register 7 IVD products all together in a timely manner. Each reagent requires clinical trial. Normally it would take 18 months per product and usually CFDA requires additional evidence during application.
The Solution: Our team worked diligently during document preparation to make sure it covers all possible regulations. Our team proactively engaged CFDA officials during application preparation to strive for prompt review attention.
The Result: All 7 registration applications were accepted with no additional evidence required. All clinical trials were accepted successfully. Within 12 months, client received all registration licenses. Our work saved six months of time for the client.