The client was a leading USA-based biopharmaceutical company who was looking for Regulatory support in filing LCM submissions for IND applications to the USFDA and end-to-end publishing activities. The project presented challenges such as tracking versions of frequently changed documents, replacing them in eCTD, and stringent timelines. Freyr offered granular Document Level Publishing services and created a tracker to track all the version changes. Freyr’s talent pool was able to make timely submissions with zero warnings and carried out all the publishing activities successfully.
Decode how Freyr was able to file valid LCM submissions for IND applications to the USFDA for a client and offered support in end-to-end publishing activities. Download the proven case.