Strategic Due Diligence
"We are clinical pharmacologists and drug developers with innate ability to aid in solving drug development challenges and developing straight forward strategies for successful therapies."
Our goal is to be there with your company during overall development of your programs, including the decisions to purchase new programs.
During our review of your programs or programs that you may want to acquire, we focus on therapeutic class, early to late development requirements, translational medicine as well as indication-specific, class related issues or opportunities to be able to enhance your position with regulators, the investors, the public and/or give you enhanced purchase power. We utilize our vast experience from prior drug programs as well as current interactions with regulatory agencies to determine the most important next steps in your programs development.
We have been involved in over 20 strategic alliance and due diligences and have been instrumental in decision making on a compound/ program/company and their assets, on either side of the table.
Our Strategic Drug Development Services
- Strategic Due diligences with clinical pharmacology strategy, clinical development and overall development focus
- Complete NDA/BLA/ANDA due diligence
- Interpretation and translation of preclinical or early human data to be able to guide for next steps in overall clinical pharmacology programs
- Review of development program with a clinical pharmacology focus to assess the overall development success
- Strategic recommendations for regulatory interactions
- Interpretation and implementation of industry guidance documents for individual clinical pharmacology development programs and their viability to be purchased or sold
- EMEA, PMDA recommendations and due diligence in support of expanding development internationally
