Navigation Links
Regulatory Affairs Associates Gets New Drugs Tested Faster, Wins 2007 Innovation Michigan Award

Micro-Plants Introduced to Accelerate Manufacture of Clinical Trial


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: )

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.

Regulatory Affairs Associates ( 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.

SOURCE Regulatory Affairs Associates, Inc.
Copyright©2007 PR Newswire.
All rights reserved

Related medicine news :

1. Handbook cum diary on regulatory information
2. Drug regulatory officials giving the nod for sale of Unapproved drug formulations in India
3. Tumor Suppressor p53s Contradictory Regulatory System
4. Human Complexity Can Be Attributed To Regulatory Sequence
5. The Lancet Calls For Review Of Regulatory Process Of Drug Trials
6. Medtronic’s Insulin Pump Receives Regulatory Approva
7. Regulatory T-cells – Protector or Cause of Diseases
8. GMC Wrestles For Regulatory Powers
9. Regulatory Mechanism for Tumor Suppressor Protein Identified
10. Structure of Iron Regulatory Protein-RNA Complex Solved
11. Ramadoss Vows to Set Up Food Regulatory Body in India
Post Your Comments:
(Date:11/25/2015)... ... November 25, 2015 , ... For the first time, Vitalalert ... Organizations, One Beat ” campaign. The partnership between the two groups began in 2014 ... MAP International’s cause. , MAP International was founded in 1954 and is an international ...
(Date:11/25/2015)... ... ... On November 25, 2015, officials of Narconon Arrowhead , the drug rehabilitation ... new cutting edge recovery program that has been 50 years in the making. ... with the purpose to free addicts from the symptoms and negative behaviors of addiction. ...
(Date:11/25/2015)... ... ... Smiles by Stevens is pleased to announce the addition of Botox® for ... aware of the benefits of Botox® in the treatment of moderate facial wrinkling, few ... and pain as a result of Jaw Tension, TMJ (temporo-mandibular joint) disorder, and Bruxism ...
(Date:11/25/2015)... ... November 25, 2015 , ... In an ongoing Clinical Study conducted by an ... IL, UV Angel is evaluating the efficacy of its product and its disinfection protocol. ... 30 beds) from May 2014 through October 2015 at a 360-bed, acute-care, academic medical ...
(Date:11/25/2015)... Spring, Md (PRWEB) , ... November 25, 2015 ... ... Pulmonary Hypertension Association (PHA) announces the nation’s Periwinkle Pioneers, individuals and groups responsible ... history of this disease. The Periwinkle Pioneers, nominated by the public, will receive ...
Breaking Medicine News(10 mins):
(Date:11/25/2015)... 2015 Kitov Pharma ceuticals ... a biopharmaceutical company focused on the development of therapeutic ... today announced the closing of its previously announced underwritten ... ), each representing 20 ordinary shares of the Company, ... ADSs and warrants were issued in a fixed combination ...
(Date:11/25/2015)...  Today AVACEN Medical announced the issue of United States patent No. ... ". This patent shields the company,s AVACEN 100 dry heat therapy medical device and specific methods ... Photo - ... ... ...
(Date:11/25/2015)... , Nov. 25, 2015 USP 800 ... drug preparations (e.g. pharmacists, pharmacy technicians, nurses, physicians, ... technicians). The chapter also covers all entities which ... pharmacies, hospitals, other healthcare institutions, patient treatment clinics, ... --> --> What is ...
Breaking Medicine Technology: