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MDS Pharma Services Earns Certification to Support Entry to Brazilian Pharma Market Print
Wednesday, 30 September 2009

Brazilian Regulator Approves MDS Facilities in Europe, U.S. to Conduct Early Clinical Research, Clinical Pharmacology and Bioanalysis

(KING OF PRUSSIA, PA) – MDS Pharma Services, a leading provider of innovative drug discovery and early stage development solutions, is pleased to announce that its early clinical research and clinical pharmacology operations in Belfast, Northern Ireland, and its clinical pharmacology and bioanalytical services operation in Lincoln, Nebraska, have been certified by the Brazilian Sanitary Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria – ANVISA).

ANVISA provides regulatory approval for drugs and other products seeking to enter the large and growing Brazilian market. ANVISA-certified service providers are uniquely qualified to help clients clear a key hurdle to access to one of the fastest-growing major pharmaceutical markets in the world.

“MDS Pharma Services is the only contract research organization in the U.K. and one of only two in the U.S. to offer clients the benefits of ANVISA certification,” said MDS Pharma Services President David Spaight. “We already have one of the most extensive early stage service portfolios in the industry, supporting Discovery through Phase IIa clinical proof-of-concept. Now we have strengthened our distinctive ability to serve clients by earning ANVISA approval to conduct early clinical, clinical pharmacology and bioanalytical research for compounds destined for the attractive Brazilian market, which is projected to exceed $18 billion by 2012.”

In addition to ANVISA certification, the MDS Pharma Services facilities have also been certified by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) and the World Health Organization (WHO). The Belfast facility has received both Standard and Supplementary Accreditation from MHRA, which certifies that the facility meets the highest standards for study participant safety and access to emergency medical response. The MHRA accreditation attests to the MDS Pharma Services commitment to participant safety and supports the recently announced strategic focus on Discovery through Phase IIa clinical proof-of-concept studies involving patients and special populations. The Lincoln facility has the distinction of being one of only two bioanalytical services locations in North America that currently are pre-approved for the WHO Priority Medicines Program.

More Information
Additional information with respect to MDS Pharma Services’ new strategic focus on Early Stage Operations (Discovery through Phase IIa) can be found on MDS Inc.’s Website at www.mdsinc.com/for_media/electronic_media_kit.asp.

About MDS Pharma Services

MDS Pharma Services, a business unit of MDS Inc., is committed to delivering quality service on time. We offer a full spectrum of resources to meet the needs of the pharmaceutical and biotechnology industries from Discovery through Phase IIa proof-of-concept studies. With numerous facilities strategically located around the world, we apply advanced scientific and technological expertise throughout the early phases of drug discovery and development – from lead identification and optimization, pre-investigational new drug (IND) research, early clinical research (bioequivalence, Phases 0, I and IIa), clinical pharmacology, bioanalytical services and early cardiac safety assessment). For more information, visit our Website at www.mdsps.com.

 

 


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