Regulatory Affairs Associates Announces Innovative FDA Medical Device Consulting Provided Within Federal Contract

Pontiac, MI, April 02, 2010 --(PR.com)-- Regulatory Affairs Associates (RAA) announced today it has been awarded the project as FDA regulatory consultants to Visca Corporation for the development of a break-through biomarker medical device. RAA participated in writing the successful contract bid to the Federal Government.

The device will analyze blood levels for radiation to help civilians and first responders during a nuclear emergency The Federal Agency HHS, Biomedical Advanced Research and Development Authority (BARDA) is funding the project. The contract award to Visca is $3,399,297 for nine months with an additional option of $32,929,916 One hundred percent of this project will be funded with Federal money.

Visca is a spin-off company from Wayne State University, College of Engineering, Smart Sensors and Integrated Microsystems in Detroit, MI. RAA is providing guidance to pursue many other medical applications that are under active development by staff and university scientists, according to its Chief Technical Officer and WSU Professor Dr. Gregory Auner. RAA also provides FDA regulatory consulting advice to other Wayne State University projects.

Regulatory Affairs Associates is an industry leader in medical device evaluation and submissions to FDA. Stephen Goldner, President and CEO said, “We are happy to be working with Visca and this innovative technology. RAA is adept at addressing the challenges put forth by this type of instrument and understands the intricacies needed to obtain the appropriate data leading to FDA clearance. We are confident FDA will appreciate this device development and give the product the best possible regulatory evaluation to protect civilians and first responders.”

Visca’s CTO, Dr. Auner said, “HHS awarded the grant based upon our novel technology and seamless integration of university research into company development and full production with FDA approval. We could not have initiated this project without the assistance of Regulatory Affairs Associates. Mr. Goldner and his team were integral in helping us obtain the BARDA grant and will continue to be a major asset in the development of our device. We look forward to working with them over the next few years as this product moves through development into production.”

Regulatory Affairs Associates is a full service drug and medical device firm providing expert FDA consulting services for companies, inventors and universities worldwide. Their experts have work in this field over 35 years bring many life sustaining drugs and medical devices to the marketplace in the USA and around the world.

###