From Pre-IND Strategy to IND Clearance—Without the Costly Surprises

Submitting an Investigational New Drug (IND) application marks a critical inflection point in the pursuit of bringing a drug to market. It signals the close of preclinical development and the start of first-in-human clinical research. Getting it right requires more than a checklist; it takes regulatory expertise, scientific precision, and a clear strategy for FDA engagement.

Lumanity’s Clinical & Regulatory team provides FDA-aligned pre-IND and IND guidance that moves sponsors efficiently from preclinical development through submission and into clinical program initiation. We combine regulatory insight with hands-on support — including IND readiness assessments designed to surface gaps before they become clinical holds.

Check out the list of resources to support your pre-IND and IND readiness.