MDS Pharma Services Granted cGMP License for Belfast Facility

May 9, 2005

Applied Clinical Trials

MHRA accreditation inspection of the business‚s pharmacy is conducted with no critical findings.

(Belfast, Northern Ireland. May 9, 2005.) -- MDS Pharma Services, a leading provider of innovative drug discovery and development solutions, has announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has issued accreditation to the pharmacy at its clinical research facility in Belfast, Northern Ireland. The pharmacy meets all Good Manufacturing Practice (cGMP) standards established by the European Union Clinical Trials Directive for manufacturing and dispensing investigational medicinal products for clinical studies at all MDS Pharma Services European early clinical research sites, including Belfast, Northern Ireland and Munich and Hamburg, Germany.

"Clients can be assured that our pharmacy is fully cGMP compliant and meets all of the rigorous standards required by the new regulations," said Terry Lenehan, vice president, Clinical Operations for MDS Pharma Services. "Clients can have the highest level of confidence that their study will be conducted fully in accordance with all of the current regulations."

MDS Pharma Services was well-prepared to meet the standards of the newly required accreditation. The company was actively involved from the earliest discussions pertaining to the EU Clinical Trials Directive and worked hand-in-hand with industry and regulatory agencies in the United Kingdom to develop the directive and smooth the path to successful implementation.

To earn the cGMP accreditation, the MDS Pharma Services Belfast pharmacy passed a rigorous MHRA inspection with no critical findings. Formed from the amalgamation of the Medicines Control Agency and the Medical Devices Agency, the MHRA is the arm of the United Kingdom Department of Health responsible for ensuring that medicines and devices supplied in the U.K. meet acceptable standards of safety, efficacy and quality.

MDS Pharma Services offers a full spectrum of resources to meet the drug discovery and development needs of the pharmaceutical and biotechnology industries. With numerous facilities strategically located around the world, the company applies advanced scientific and technological expertise to each stage of the drug discovery and development process

  • Early Stage: lead optimisation, pre-IND research, pharmaceutical and biopharmaceutical development, early clinical research (bioequivalence, phases I-IIa) and bioanalysis; and
  • Late Stage: global clinical development (phases IIb-IV) and central lab.

For more information, visit MDS Pharma Services' Web site at www.mdsps.com.

MDS Pharma Services is an integral part of MDS Inc. (TSX: MDS; NYSE: MDZ). MDS Inc. has more than 9,000 highly skilled people in 25 countries providing a diverse range of superior products and services to increase our customers' speed, precision and productivity in the drug development and disease diagnosis processes. We are a global health and life sciences company, recognised for our reliability and collaborative relationships. Please refer to our website at www.mdsintl.com to find out more about how we help create better outcomes in the treatment of disease.