Clinical testing

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Clinical testing

The clinical testing laboratories are involved in the generic drug bioequivalence and clinical testing are required to submit the GDUFA self-identification. Foreign companies are also required to appoint U.S. Agent to act as the point contact for the FDA to communicate on behalf of foreign manufacturers.

We can act as your U.S. Agent and assist you in submitting the GDUFA self-identification. Please contact for more information.

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