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:3/24/2017)... ... March 24, 2017 , ... Digital Scientists, a software ... announce the opening of a Greenville, South Carolina location. The lab has ... in Greenville. , “We’ve been working with South Carolina clients for years from our ...
(Date:3/24/2017)... ... March 24, 2017 , ... ... related services to families and business owners across eastern Michigan, is connecting with ... families struggling with financial difficulties. , The Oxford/Orion FISH Food Pantry works to ...
(Date:3/24/2017)... , ... March 24, 2017 , ... ... panels at the Advanced ERISA Benefit Claims Litigation seminar in Chicago, Illinois. ... Administrative Record, The majority of cases litigated under ERISA involve claims for long-term ...
(Date:3/24/2017)... ... 24, 2017 , ... Judy Buchanan, co-owner of Serenity Natural ... Judy says, “I am passionate about sharing Reiki as a holistic, complementary therapy ... challenging time.” , A Certified Medical Reiki™ Master trained by Raven Keys Medical ...
(Date:3/24/2017)... ... 2017 , ... “The Adventures of Joey, The Dog Who Barks at Puddles”: ... life to the fullest, as God intended. “The Adventures of Joey, The Dog Who ... grandmother pursuing her passion for writing, especially about truth and human behavior. , Published ...
Breaking Medicine News(10 mins):
(Date:3/24/2017)... , Mar. 24, 2017 Research and Markets has ... Development, Growth and Demand Forecast to 2022" report to their offering. ... The global wound care ... grow at a CAGR of 6.7% during 2016-2022 Among the ... the largest share in the global market in 2015. Among the various ...
(Date:3/24/2017)... Research and Markets has announced the addition of the "Dental Implants ... ... for Dental Implants in US$ Million. The report provides separate comprehensive analytics ... , Europe , Asia-Pacific , ... Annual estimates and forecasts are provided for the period 2015 through 2022. ...
(Date:3/24/2017)... , March 24, 2017 ... providing high-quality and cost-effective drug development and ... pharmaceutical and biotechnology industry, announced today the ... ShangPharma will be consolidating the Contract ... (CMO) under Shanghai ChemPartner. These entities include ...
Breaking Medicine Technology: