Clinical and regulatory due diligence of an asset targeting pre-term birth complications

Challenge:

Our client was a European mid-size pharmaceutical company considering an investment in a clinical-stage company developing an asset for multiple indications associated with pre-term birth complications.

In this instance, the client required a Clinical and Regulatory Affairs specialist with specific knowledge of US and European regulatory requirements for registration in these indications. 

Solution:

Alacrita’s experts performed a targeted clinical and regulatory due diligence applying up-to-date understanding of regulatory positions in the field and a particular focus on the following points of concern:

• Ensuring prior regulatory advice was being followed.
• Likelihood of accelerated (FDA) or conditional (EMA) approval of the various clinical indications. 

After direct discussion with the target company our findings were detailed in a PowerPoint report to illustrate key risks in the investment, ranked by impact. 

Due Diligence Consulting

Alacrita due diligence consultants have been a trusted DD source for close to fifteen years, conducting assignments for large pharma, biotech, universities and investors. Every due diligence we perform is underpinned by our ability to incorporate individuals into each project who have the exact matching expertise required for a complete, thorough and accurate assessment.