Technical Due Diligence
Technical Due Diligence
Licensing and acquisition are a common way for small pharma and start-ups to grow. However without the right technical and business experience, you may end up licensing or acquiring a pharmaceutical product, patent, or technology that ultimately does not work, leading to lost time and money or, even worse, complete company failure.
The management team at Vici Health Sciences has many years of experience evaluating products and technologies for acquisition. We can perform a due diligence, focusing on:
- Robustness of intellectual property protecting the asset
- All CMC (chemistry manufacturing and control) aspects of the asset(s) including the formulation, analytical test methods, manufacturing process, and control strategy
- All raw materials and their compliance to current standards
- Evaluation of product specifications per current FDA expectations.
- The entire supply chain and complete risk assessment of the supply chain
- Review of additional clinical studies (such as pediatric studies) that may be required to commercialize the asset
- All FDA commitments associated with the asset
- All cGMP and quality related risks associated with the asset
A comprehensive review can significantly decrease your risk, saving you time and money later down the road.
We are your in-house R&D team. Get in contact with us before licensing or purchasing an asset. Prioritizing the need for doing a comprehensive review can and will significantly decrease your risk, saving you time and money later down the road.