We Can Help Move Your Drug Development Process Forward
The development of an Investigational New Drug Application (IND) 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 really started. IND Preperation requires understanding of FDA rules and exceptions, focusing on removing blockers from the process, and maintaining forward momentum.
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.