Challenge: A world leader in tissue-based cancer diagnostics based in Denmark was notified by the FDA that it was not in compliance with the ASR regulation. The company submitted a project plan to become compliant, but after the FDA did not respond for more than a year, the company sought assistance resolving the issue and dealing with the FDA.

Beaufort Solution: Beaufort helped the company resolve ASR compliance issues with the pre-IDE submission and crafted an appropriate pre-IDE submission and project plan. Prior to mediating the pre-IDE meeting with the FDA, Beaufort helped the company develop a presentation and assisted with a dress rehearsal.

Date posted: December 2, 2011

Categories: Case Studies Regulatory Affairs