Regulatory Affairs services

Regulatory Intelligence (RI) is the act of gathering and analyzing regulatory information. This information resides in both print and electronic media. Regulatory guidances, regulatory precedence, industry practices, market analysis, and competitor information are just a few of the valuable tools of RI activity.

Regulatory Strategy (RS) evolves from careful assessment of RI and from understanding your business objectives and goals. RS frames the overall development plan and helps determine the fastest path to market with the greatest value. As RI is always changing, RS must also be dynamic to continually reduce risk while sustaining or improving potential benefit. RI/RS services are flexible to client needs and to developmental stage.

Regulatory Due Diligence (RD) involves evaluating value proposition and risk/benefit while considering regulatory history, manufacturing practice, nonclinical data, and clinical data. We can assist with both buy- and sell-side diligence, including data room creation and maintenance thoroughout your development program. It's never too early to carefully plan for your exit. Both investors and partners will value your RD predaredness.