IND Preparation
We Can Help Move Your Drug
Development Process Forward
The development of an Investigational New Drug (IND) Application is no simple matter and is required by the FDA prior to any testing of a product in humans. Navigating this piece of the drug development process can get many teams stuck before they've even started. IND Preparation requires an understanding of FDA rules and exceptions, focusing on removing blockers from the process, and maintaining forward momentum.
Our team has the experience necessary to ensure the IND process for your project proceeds smoothly.
What Does the Proof of Concept Study Process Look Like?
If you're facing an upcoming IND submission, we'd like to hear from you. We can help you understand your options, present applications to the FDA, and build proof of concept studies.
