Handling of Discipline Review Letter from the USFDA for an ANDA Approval

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 Discipline Review Letter (DRL) from the FDA for an ANDA approval. There were several challenges in the project such as stringent timelines and a lack of expertise in handling DRL. Freyr evaluated the queries from the FDA and prepared a foolproof strategy for a response. Freyr compiled the response based on the dossier and discussed it with the client. The documents were then prepared as per the relevant Regulatory requirements and the response was submitted to the FDA within the timeframe.

Explore how Freyr was able to offer timely Regulatory support to the client in handling the response for the DRL from the FDA by identifying the gaps and following a compliant submission strategy for the ANDA approval. Download the proven case.

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