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

a china-based pharmaceutical company delivers a 4 GB DMF submission with zero validation issues using FREYR

A China-based pharmaceutical company needed support to file a complex Drug Master File (DMF) application with the US FDA as part of its global expansion. The client faced challenges with tight submission timelines, frequent document revisions, and the technical complexities of compiling a 4 GB submission that complied with strict FDA requirements. They engaged FREYR for its DMF application publishing and submission support services.

FREYR implemented a comprehensive solution that included creating a detailed submission roadmap, performing granular document publishing, and establishing rigorous version control and quality checks. This enabled the successful delivery of the massive submission with zero validation issues. FREYR's support resulted in a 70% increase in cost efficiency for the client and accelerated the regulatory review process, all while meeting the aggressive timeline through a 24x7 global delivery model.