The client was a USA-based Contract Research and Manufacturing Services (CRAMS) firm specializing in drug discovery and development and was seeking Regulatory support in safety-label change notification for an NDA. The biggest challenge in the project was stringent timelines for the submission of the documents. Freyr was able to update the USPI based on the safety-label change notification received from the USFDA in a timely manner and provide cost-effective services to the client.
Learn more about how Freyr was able to offer Regulatory support to the client in submitting the labeling documents per the USFDA guidelines. Download the proven case.