Case Study: a US-based pharmaceutical company achieves seamless regulatory continuity with FREYR

US based pharmaceutical company stabilizes 70+ ANDAs/NDAs with FREYR

A US-based pharmaceutical company with a lean regulatory team and high attrition struggled to manage the ongoing submissions and lifecycle events for its diverse portfolio of over 70 ANDAs/NDAs. FREYR became an end-to-end regulatory partner to provide comprehensive regulatory operations and ensure business continuity.

FREYR implemented a blended on-site and offshore regulatory operations model, deploying dedicated experts and buffer resources to manage the entire workload. This solution ensured seamless business continuity for the complex portfolio, reduced overhead for the client through a flexible staffing model, and maintained compliance for all products, turning the resource-strained team into a scalable, stable operation.