The client was a French biotechnology company looking for Regulatory support in making IND submissions in the eCTD format and filing of SUSAR, safety reports, a change in the USA agent, and new investigator’s information. The project presented with challenges such as tracking of frequently changed documents and a defined period for filing them in the eCTD format. Freyr validated the documents and ensured 100% accuracy in the submissions with quick turnaround time. Freyr’s talent pool met all the client’s requirements and helped them in their business objectives.
Discover how Freyr was able to work in strict timelines and provide valid submissions with zero defects and warnings. Download the proven case.