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.

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