Due Diligence of Pharmaceuticals (Small Molecules and Biologics)

Nuventra’s senior level consultants can provide expert assistance with due diligence of pharmaceuticals (small molecules) and biologics that companies are looking to in-license/out-license. Utilizing Nuventra’s consultants extensive experience in drug development, we can evaluate all nonclinical data, including animal PK, DMPK, in vitro/in vivo data, etc. combined with all clinical pharmacokinetic and clinical pharmacology investigations to provide a comprehensive assessment of legacy data and challenges moving forward for each drug. Analysis of regulatory interactions related to nonclinical, clinical pharmacology, and pharmacokinetic issues would also be conducted in a typical due diligence exercise to assess the level of FDA interaction to date and agreements made with the FDA for future studies/investigations.

Nuventra provides insight into each compound’s history and future, which gives companies the confidence to proceed with the licensing opportunity or to avoid a given compound due to liabilities associated with the drug.