Skip to main content

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:

20/20 GeneSystems
21st Century Therapeutics
A&G Pharma
Advanced Cell Diagnostics
Ambergen
American BioOptics
Bexion Pharmaceuticals
BioElectro Med
Biothera
C4 Imaging
Civatech Oncology
Creatv MicroTech
CytonomeST
Dekk-Tec
Etubics
Gencia
GLC Biotechnology
Insight Genetics
Intrinsic Bioprobes
JSK Therapeutics
Koning Corp
Laser Biopsy
MagArray
Materials Development
Medicon
Medigen
MyeloRx
NanoIVD
Nanoparticle Biochem
Nanoprobes
Nanoscale Corp
Omniox
Optimum Therapeutics
PDS Biotech
PharmaSeq
Physical Sciences
Piezo Resonance Innovations
Praevium Research
Presage Biosciences
Quintessence Biosciences
Real Time Tomography
SibTech
Silagene
Source Production & Equipment
Stern Magnetics
Talaria
Targeson
Vestan
Vitatex
XL Sci-Tech
Zenalux Biomedical
Zumatek