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
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.
Improving Relationships and Diversifying the Site Selection Process
April 17th 2025In this episode of the Applied Clinical Trials Podcast, Liz Beatty, co-founder and chief strategy officer, Inato, discusses a number of topics around site engagement including community-based sites, the role of technology in improving site/sponsor relationships, how increased operational costs are impacting the industry, and more.
Behind the Buzz: Why Clinical Research Leaders Flock to SCOPE Summit
February 7th 2025In this episode, we meet with Micah Lieberman, Executive Conference Director for SCOPE Summit (Summit for Clinical Ops Executives) at Cambridge Innovation Institute. We will dive deep into the critical role of collaboration within the clinical research ecosystem. How do we bring together diverse stakeholders—sponsors, CROs, clinical trial tech innovators, suppliers, patients, sites, advocacy organizations, investors, and non-profits—to share best practices in trial design, program planning, innovation, and clinical operations? We’ll explore why it’s vital for thought leaders to step beyond their own organizations and learn from others, exchanging ideas that drive advancements in clinical research. Additionally, we’ll discuss the pivotal role of scientific conferences like SCOPE Summit in fostering these essential connections and collaborations, helping shape the future of clinical trials. Join us as we uncover how collective wisdom and cross-industry partnerships are transforming the landscape of clinical research.
FDA-Approved Gene Therapy Beqvez Shows Sustained Efficacy, Safety in Long-Term Hemophilia B Trial
April 17th 2025Beqvez (fidanacogene elaparvovec), an FDA-approved one-time gene therapy for hemophilia B, demonstrated sustained factor IX expression, low bleeding rates, and a favorable safety profile over long-term follow-up.