Case Study: a US-based multinational pharmaceutical company achieves EAEU eCTD compliance with Freyr

a UK-based pharmaceutical company achieves EAEU compliance with FREYR

A US-based multinational pharmaceutical company needed to transition from paper-based regulatory submissions to eCTD-compliant formats to meet Eurasian Economic Union (EAEU) requirements. Lacking regional expertise, the company faced significant compliance risks and operational challenges. They partnered with FREYR for expert eCTD consultation and implementation support to navigate this complex transition.

FREYR provided end-to-end consultation and technical publishing support. This included a comprehensive gap assessment, the development of a transition roadmap, and hands-on dossier conversion. As a result, FREYR successfully transitioned the client's submission processes to electronic formats, achieving full EAEU compliance, reducing regulatory risk, and establishing a scalable framework for future submissions.