The client was a USA-based pediatric hospital that was looking for Regulatory support in filing DMF submission to the USFDA and end-to-end publishing activities. The project presented several challenges such as stringent timelines for filing a high-quality submission, tracking versions of frequently changed documents, and replacing the same in eCTD. Freyr, with its dedicated Publishing & Submissions team, filed the submission within the timelines and ensured there were zero errors in them while taking care of the publishing activities.

Decode how Freyr worked within defined timelines to file the DMF submission to the USFDA while offering support in the client’s publishing activities. Download the proven case.