The client was a USA-based biopharmaceutical company developing novel drugs and was looking for Regulatory support in filing LCM submissions for IND applications to the USFDA. The project presented several challenges such as stringent timelines for filing high-quality submissions, tracking versions of frequently changed documents, and end-to-end publishing activities. Freyr, with its highly talented publishing and submissions resources, was able to file all the submissions and complete the publishing activities within the timelines with zero errors from the Agency.
Decode how Freyr worked against time to file the LCM submissions for IND applications to the USFDA while taking care of end-to-end publishing activities. Download the proven case.