An India based pharmaceutical company specialized in Oncology APIs approached Freyr for Regulatory support with filing DMFs to the USFDA. The challenge was to file the DMF along with tracking the amendments made to the documents and managing them in eCTD format. Freyr assisted the client by deploying a full-time dedicated team of resources to ensure successful and timely submission.

Read through the case study to decode Freyr’s approach in handling DMF submission with 100% accuracy.