Challenge: A leader in molecular-based diagnostic tests and testing platforms sought assistance in developing its regulatory strategy for repositioning several analyte-specific reagents (ASRs).

Beaufort Solution: The company wanted a comprehensive regulatory perspective encompassing the various potential pathways for converting ASRs into diagnostic kits, as well as assistance in creating the pre-IDE information packages for each product.  Working with the company’s internal resources, Beaufort completed this assignment, and, in addition, reviewed relevant literature and created a pre-IDE information package which included a high level clinical trial protocol for FDA review.

Date posted: October 27, 2011

Categories: Case Studies Regulatory Affairs