Challenge:
Our client was a pharmaceutical company considering an acquisition of two approved assets and required expert due diligence on the clinical, regulatory and manufacturing aspects of the two programs, with a particular focus on life cycle management strategies.
Solution:
Alacrita’s experts performed a targeted clinical, regulatory, and manufacturing due diligence with a particular focus on the following points of concern:
- Likelihood of meeting FDA timelines for post-marketing studies, and impact of not meeting timelines.
- Remaining risks or concerns in the NDAs for the two drug products.
- Likelihood of approval of label expansions and impact if approval is not granted.
- Feasibility and timelines for the drug-device life cycle management strategies.
We found the target company was ill-prepared for a due diligence of this nature and its predicted timelines and assumptions for label expansions were unlikely to be met.
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.