IND/First-in-Man enabling studies are a critical milestone in the drug development process. Navigating to a successful IND submission while simultaneously maximizing the value/efficacy of your drug product can be very challenging, with multiple important decisions along the way. Whether our clients have bioavailability issues, financial constraints, or accelerated deadlines, having a complete development plan for your lead candidate can make the difference between success and failure.
IND/First in Man Studies and Related Services:
- Formulation-enabling studies to progress to IND/First-in-Man submission
- Identification and resolve of drug product challenges
- Formulation strategies to advance oral drug products to IND/First-in-Man
- Process strategies to progress sterile drug products to IND/First-in-Man
Our state-of-the-art labs are staffed by some of the best trained and most experienced subject matter experts in the field.