Regulatory Assistance Program

About the Regulatory Assistance Program*
Regulatory Assistance Program Participants

*Note: Applications for the Regulatory Assistance Program are no longer being accepted. Please see below for a list of the SBIR-supported company participants.

About the Regulatory Assistance Program:
The NCI SBIR Regulatory Assistance Program was a pilot initiative designed to help Phase I and Phase II grantees and contractors navigate the regulatory pathway.

Participants were selected on a competitive basis for the pilot program. The first round of Regulatory Assistance Program participants was announced in March 2011.

The program provides selected NCI SBIR-funded companies with up to 30 hours of regulatory consultant time in the therapeutics and medical device areas. Consultant services are used to help the selected companies develop a comprehensive regulatory plan aimed at optimizing each company's movement through the FDA approval process.

The National Cancer Institute SBIR Regulatory Assistance Program is funded by NCI SBIR and executed by Regulatory Affairs Associates. The program is part of the NCI SBIR's efforts to go beyond funding support to help small businesses bring innovative cancer products to market to help researchers, providers, and patients fight cancer.

NCI SBIR Regulatory Assistance Program Participants: