When considering an acquisition or an in-licensing opportunity, it is important to ensure that all regulatory issues and potential approval hurdles are identified, and plans put in place to mitigate any gaps. Our experts can conduct an independent review(s) as part of the due diligence efforts including:

1. Conduct and author audit report(s) following due diligence
2. Review and assess all FDA-sponsor communications
3. Review and assess possible gaps in clinical, non-clinical and CMC submissions
4. Assess risks including evaluation of regulatory hurdles and potential show stoppers