Case Study: a China-based pharmaceutical company achieves successful FDA DMF submission with FREYR

China-based Pharmaceutical Company achieves 70% cost efficiency with FREYR for FDA DMF submission

A China-based pharmaceutical company faced challenges in submitting a Drug Master File (DMF) application to the US FDA. They struggled with managing frequent document revisions, splitting files to meet FDA size requirements, and compiling complex reports. The vendor, FREYR, was engaged to provide support and ensure a compliant submission.

FREYR implemented a solution that included creating a submission roadmap, performing granular document publishing, and using a detailed tracker to manage revisions. This process, which featured a two-stage quality check, resulted in the successful delivery of a 4 GB submission with zero validation issues. FREYR's support helped the client achieve a 70% increase in cost efficiency and accelerated the approval process, putting them ahead of their competition.