A U.S. based vaccines and related products company approached Freyr for assistance in filing IND application to the USFDA. The company was facing challenges while decoding the requirements of the Agency and to keep a track of the frequently changed documents and maintaining them in eCTD format.

Read through the case study to decode how Freyr managed to file compliant IND application with zero deficiency and warnings with 100% accuracy while adhering to the strict timelines.

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