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

Regulatory Affairs Associates (http://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.


'/>"/>
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:
*Name:
*Comment:
*Email:
(Date:12/5/2016)... (PRWEB) , ... December 05, 2016 , ... ... ability of physical therapist assistants, under direct supervision of a licensed physical therapist, ... physical therapy receives a consultation and treatment plan from a licensed physical therapist ...
(Date:12/5/2016)... Switzerland (PRWEB) , ... December ... ... between professional calibrations is an excellent way to ensure moisture measurements are ... are time-consuming and impractical. , Now, METTLER TOLEDO offers a solution: ...
(Date:12/4/2016)... ... December 02, 2016 , ... Metabolic Code (MC) and Power2Practice ... help doctors more efficiently manage their practice. Power2Practice is adding MC’s nutraceutical ... Integrative and Functional Medicine. , The Metabolic Code platform provides a leading-edge ...
(Date:12/4/2016)... ... December 03, 2016 , ... ... Surgical Body Shaping" at the 2016 Anti-Aging & Beauty Awards at ... , The Aesthetic & Anti-Aging Medicine European Congress (AMEC) brings together the ...
(Date:12/4/2016)... ... December 04, 2016 , ... Are You Concerned About Mold In Your Home ... Indoor Air Quality Companies in VA, MD and DC, recently completed its application for ... new mold law in the district of Columbia is a good thing stated John ...
Breaking Medicine News(10 mins):
(Date:12/5/2016)... PITTSBURGH , Dec. 5, 2016  Wellbridge Health and ... innovative digital health solutions to Medicare and Medicaid plan members ... effort targeted at the unique needs of this group of ... on social work philosophies to provide insight into members, daily ... , ...
(Date:12/5/2016)... WOONSOCKET, R.I. , Dec. 5, 2016 /PRNewswire/ ... CVS ) Research Institute and the U.S. ... the Assistant Secretary for Preparedness and Response (ASPR), ... showed that automated pharmacy notifications encourage patients ... a forecasted natural disaster. The study also affirms ...
(Date:12/5/2016)... , Dec. 5, 2016  BD (Becton, Dickinson ... global medical technology company, will demonstrate an enhanced technology ... management technologies, including the company,s leading Pyxis™ and Alaris™ ... Pharmacists (ASHP) 2016 Midyear Meeting being held in ... While national data show that approximately 68 ...
Breaking Medicine Technology: