Investigational New Drug (IND) Applications and Submissions

Obtaining Investigational New Drug (IND) approval from the Food and Drug Administration (FDA) is the first step towards beginning your clinical trials in the United States. Getting here required hard work and a great Pre-IND Meeting strategy, but you still need FDA approval on your IND application before you can ship your drug across state lines and begin clinical trials.

The sooner you can begin your clinical trials, the sooner your product will be on the market. To prevent any hiccups in this process, your final IND submission must be error-free and contain all required information including animal pharmacology and toxicology studies, manufacturer and investigator information, along with detailed protocols for your upcoming clinical trials.

No matter where you are in the IND application or submission process, our IND consultants can provide guidance to assist with the remaining steps.

Fill out the form on the right to contact our IND consultants to learn more and get started today!

Types of INDs

INDs fall into two categories:

Commercial IND: Commercial INDs are used when the Sponsor intends to bring the drug to the open market. This means commercial INDs can apply to drugs created by non-profit groups who intend to eventually put the drug on the open market. The application process and timeline for a Commercial IND is much longer and more complex than for a Research IND.

Research IND: Research INDs are used when the intention is to prove efficacy for a new indication of an already approved drug. Research IND applications are submitted by physicians, and with a process that is less complex than Commercial INDs. For example, Research INDs typically involve fewer investigators and are often done at a single testing site.

Get Expert Guidance From an IND Consultant for Your Upcoming Submission