FARMINGTON HILLS, Mich., Oct. 17 Regulatory AffairsAssociates (RAA), a Michigan company specializing in winning FDA approval fornew drugs and medical devices, has been honored as a recipient of the 2007Innovation Michigan award. RAA received the award for its development of afast-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 anexpensive, critical step for biotechnology companies working on new drugs.RAA's "New Drug Xpeditor" (NDX) program uses a micro-plant model to slash boththe time and money required for this effort. Says Norm Howe, RAA's Director ofManufacturing Services, "What we have done is turn an arduous serial processinto a highly efficient collection of simultaneous, parallel processes. Theresults are experimental drugs produced to FDA quality standards in a fractionof the time and money. NDX has the ability to accelerate most drug developmentprojects and save many more that could be shelved for lack of funds."
Regulatory Affairs Associates, which delivers its NDX micro-plant programunder its RAA Pharma Manufacturing Services unit, was one of 15 honorees onOctober 4th at Michigan Business Review's Innovation Michigan 2007 celebrationin Dearborn, Michigan. RAA was lauded in the category of "InnovativeProcesses" for its ground-breaking methodology.
"NDX is one new way RAA can help emerging biotech companies successfullydevelop promising new drugs that may save lives or reduce suffering," saysSteve Goldner, RAA's president and founder. "It's gratifying work and we'reproud to have achieved this recognition."
Sponsored by Michigan Business Review magazine, the Innovative Michiganawards honor Michigan companies whose products, processes or businessstrategies are distinguished from their peers.
Regulatory Affairs Associates (www.regaffairs.net) is a privately heldMichigan company that helps biotechnology firms bring new drugs and medicaldevices to market. The company is a highly regarded expert at navigating thecomplex FDA approval process. RAA's Pharma Manufacturing and Research Servicesunits provide its U.S. and foreign-based clients with experimental drugproduction, pre-clinical toxicology studies and contract clinical researchservices. RAA's innovative business model brings highly experienced drug anddevice development professionals from around the world into collaborationusing the latest communications and Internet technologies.
SOURCE Regulatory Affairs Associates, Inc.