US Agent, Establishment Registration, and FEI assistance for Testing Facilities
Drug testing laboratory
The contract testing laboratories is involved in the generic drug testing are required to register their facility and submit the GDUFA self-identification. Foreign companies are also required to appoint U.S. Agent to act as point contact for the FDA to communicate on behalf of foreign manufacturer.
We can act as your U.S. Agent and assist you to register and submit the GDUFA self identification. Please contact for more information.