A Swiss-based biopharmaceutical company was looking for assistance in the Regulatory submission of the original IND and amendments for the USFDA. The project aimed to deliver high-quality INDs with large volumes of eCTD modules 4 and 5 within defined timelines. In addition to this, there were other challenges associated with tracking versions of frequently changed documents and replacing the same in eCTD.

Download the proven case to discover how Freyr enabled the client to meet all the submission requirements by performing end-to-end publishing activities within rapid delivery timelines.