The client was a leading Indian pharmaceutical company who was looking for Regulatory support in filing a DMF submission for a BLA to the Agency. The project came with challenges such as tracking multiple revisions in the voluminous documents sent by the client, coordinating with global/virtual teams, and stringent timelines. Freyr’s talent pool created a tracker to check all the changes in the documents and validated them using a two-stage QC process, including the rosetta view. Freyr was able to deliver the DMF submissions within the timelines with zero deficiency comments and with cost savings of over 70%.
Decode how Freyr was able to make timely DMF original submissions to the CDSCO with zero defects. Download the proven case.