The client was a USA-based drug manufacturer and was looking for Regulatory support for the evaluation, compilation, and submission of the response to a Complete Response Letter (CRL) from the FDA for an ANDA approval. The project presented several challenges that included inexperience in handling the CLR for ANDA and submissions that had to be compliant with GDUFA and RTR requirements. Freyr evaluated the queries from the FDA and prepared an accurate action plan. Freyr identified the gaps and helped in mitigating the risks by coordinating with the CMOs and all other stakeholders. Our talent pool was successful in compiling technical inputs from a Regulatory perspective and Freyr was able to meet the client requirements by submitting the response package on time.

Discover how Freyr was able to offer expert Regulatory support to the client in handling the response for the CRL from the FDA by submitting it in a compliant manner. Download the proven case.