The client is a U.S. based fast growing biotechnology company. To support them with end-to-end activities for some of their orphan drug submissions to the USFDA, the client was looking for a Regulatory expert. Freyr assisted the client with the overall product activities along with developing technical documents and other orphan drug related Regulatory activities.

Download the case study to decode how Freyr provided the client end-to-end Regulatory support for ODD and accelerated the submission process.