Regulatory Affairs Associates Gets New Drugs Tested Faster

PharmaManufacturing.com
10/18/2007

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."

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 Business Review magazine, the Innovative Michigan awards honor Michigan companies whose products, processes or business strategies are distinguished from their peers.

About Regulatory Affairs Associates

Regulatory Affairs Associates (www.regaffairs.net) is a privately held Michigan company that helps biotechnology firms bring new drugs and medical devices to market. The company is a highly regarded expert at navigating the complex FDA approval process. RAA's Pharma Manufacturing and Research Services units provide its U.S. and foreign-based clients with experimental drug production, pre-clinical toxicology studies and contract clinical research services. RAA's innovative business model brings highly experienced drug and device development professionals from around the world into collaboration using the latest communications and Internet technologies.