Case Study: a US pharma company achieves zero regulatory rejections with Freyr

US Pharma Company achieves zero rejections for 15+ ANDAs/NDAs with FREYR

The US Pharma Company, a US-based pharmaceutical firm, faced significant challenges due to the absence of an internal regulatory department. This gap threatened the quality and timelines of their 15 ANDA/NDA submissions, caused poor coordination with partners, and created a risk of non-compliance with FDA requirements. To address this, they partnered with FREYR for complete end-to-end regulatory operations services.

FREYR became the client's virtual regulatory department, establishing robust coordination and designing submission strategies. The solution included end-to-end publishing, health authority interactions, and lifecycle management. As a result, FREYR achieved zero regulatory rejections across all submissions, ensured business continuity, and freed the client's internal resources to focus on R&D and commercial priorities.