Challenge: A start-up biotechnology company needed a regulatory strategy designed to reposition a previously withdrawn compound.

Beaufort Solution: Founded by an academic physician, a chemist, and a business person, the company had a clear vision regarding its business objectives but lacked the expertise necessary to navigate the FDA regulatory maze. As a result, its initial in-house orphan disease application was rejected by FDA.  Realizing its need for experienced guidance, the company engaged Beaufort to develop a comprehensive regulatory strategy taking the compound’s history into consideration.  Beaufort prepared a new orphan drug application, which was cleared in one review cycle.  Beaufort also provided ready-to-use information for investor and academic presentations.  Since engaging Beaufort, the company has increased fundraising, cleared an additional orphan drug application, and is proceeding with a sound regulatory strategy.

Date posted: October 27, 2011

Categories: Case Studies Regulatory Affairs