A US-based leading generics pharmaceutical company was looking for Regulatory support with the filing of meeting requests to the US FDA for an Abbreviated New Drug Application (ANDA). The client was a new player in the generic market and the project had to be completed within strict timelines.

With a two-step review process, Freyr’s Publishing & Submissions team was successful in filing high-quality meeting requests for ANDA. Freyr maintained transparency with the client throughout the process by conducting timely meetings with them and understanding their requirements.

For a detailed understanding of how Freyr’s team made on-time submissions to the US FDA and ensured that the customer met all the Regulatory requirements in a compliant manner, download the proven case.