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.