A US based generic pharmaceutical company approached Freyr for providing Regulatory publishing and submissions support. The objective was to file original ANDA applications qualitatively in stringent timelines. The scope included study and review of all the documents as per the PDF specifications of FDA, revising the eCTD in compatible documents etc.

Download the case to comprehend how Freyr assisted the client to achieve zero “error and warning” submissions while reducing the overall turnaround time.