Regulatory Affairs Services

A global pharma company developing a complex generic injectable faced persistent issues during development. Freyr’s efficient planning helped the client clarify expectations, derisk the program, and advance with a clear Regulatory strategy.

A US pharmaceutical company, with a lean Regulatory CMC team and high attrition, struggled to manage over 70 ANDAs/NDAs. Freyr became an end-to-end Regulatory partner, stabilizing operations, filling critical roles, and maintaining compliance.

A complete Regulatory operations ownership right from strategy to timely filings translated into zero rejections for 15 ANDA/ NDAs for our customer.

An innovative medicines company required extensive Regulatory support for initial submissions, market expansion, post-approval lifecycle management, and compliance monitoring. Freyr provided a comprehensive operating model that included strategy development, dossier preparation, publishing, managing health authority responses, and handling variations.

An Italy-based multinational company aimed to introduce a therapy for arthritis and muscular dystrophy to the EU and US markets but lacked expertise in FDA and EMA requirements and IND oversight. Freyr provided a regulatory strategy for IND maintenance, NDA/MAA submissions, and DMF filings, enabling market access.

Freyr’s targeted BLA strategy and efficient CMO coordination helped the Italian client secure approvals and boost internal capabilities.

Freyr’s streamlined approach, robust evaluation, and coordination of cross-functional strategy enabled the timely submission of our US customer's annual report.

A global pharma company sought US FDA approval and needed expert Regulatory support to avoid delays. Freyr aided the process with a submission-focused approach, enabling first-cycle success and reducing compliance risk.