IND Enabling

Investigational New Drug (IND) enabling is a critical phase in drug development process where extensive preclinical studies are conducted to generate the necessary data which gets a new drug into the clinic.Advancing the best candidate for regulatory submissions requires a careful assessment of efficacy and toxicity prior to entering human trials The IND-enabling testing includes a series of toxicology studies in two species with supporting pharmacokinetic and bioanalytical data, safety pharmacology studies and genetic toxicology. However, a comprehensive IND-enabling program is dependent on the full clinical plan: class of drug, route of administration, dose, duration of treatment and planned indication. ‍Contact us today to find out how we can support and accelerate this next phase in drug development from enabling a synthetic route to your drug substance to further de-risking activities on your drug product. ‍