Case Study: a US-based pharmaceutical company achieves seamless management of 70+ ANDAs and NDAs with FREYR

a US-based pharmaceutical company streamlines 70+ ANDAs and NDAs with FREYR

a us-based pharmaceutical company faced significant challenges in managing the regulatory lifecycle for its portfolio of over 70 ANDAs and NDAs. With a limited number of internal resources and a lack of expertise in comprehensive regulatory services, they were unable to effectively handle submissions and post-approval change management. They engaged FREYR for end-to-end regulatory support and staffing solutions.

FREYR implemented a solution utilizing dedicated on-site and offshore regulatory experts to provide comprehensive support. This included strategic guidance, submission management, and the allocation of buffer resources for ad-hoc requests. As a result, FREYR ensured business continuity for the client, provided significant overhead cost benefits, and successfully maintained all registration requirements for the extensive product portfolio.