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Regulatory Affairs Associates Gets New Drugs Tested Faster, Wins 2007 Innovation Michigan Award
Date:10/17/2007

Micro-Plants Introduced to Accelerate Manufacture of Clinical Trial

Pharmaceuticals

FARMINGTON HILLS, Mich., Oct. 17 /PRNewswire/ -- Regulatory Affairs Associates (RAA), a Michigan company specializing in winning FDA approval for new drugs and medical devices, has been honored as a recipient of the 2007 Innovation Michigan award. RAA received the award for its development of a fast-track process for the manufacture of drugs used in clinical trials called "NDX."

(Photo: http://www.newscom.com/cgi-bin/prnh/20071017/CLW136 )

Production of experimental drugs for use in clinical trials is an expensive, critical step for biotechnology companies working on new drugs. RAA's "New Drug Xpeditor" (NDX) program uses a micro-plant model to slash both the time and money required for this effort. Says Norm Howe, RAA's Director of Manufacturing Services, "What we have done is turn an arduous serial process into a highly efficient collection of simultaneous, parallel processes. The results are experimental drugs produced to FDA quality standards in a fraction of the time and money. NDX has the ability to accelerate most drug development projects and save many more that could be shelved for lack of funds."

Regulatory Affairs Associates, which delivers its NDX micro-plant program under its RAA Pharma Manufacturing Services unit, was one of 15 honorees on October 4th at Michigan Business Review's Innovation Michigan 2007 celebration in Dearborn, Michigan. RAA was lauded in the category of "Innovative Processes" for its ground-breaking methodology.

"NDX is one new way RAA can help emerging biotech companies successfully develop promising new drugs that may save lives or reduce suffering," says Steve Goldner, RAA's president and founder. "It's gratifying work and we're proud to have achieved this recognition."

Sponsored by Michigan Bu
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SOURCE Regulatory Affairs Associates, Inc.
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