Quintiles Transnational Corp. (Research Triangle Park, NC) has acquired Oak Grove Technologies Inc., a specialist in providing current Good Manufacturing Practice (cGMP) compliance services to the pharmaceutical, biotechnology and medical device industries.
Oak Grove provides services related to manufacturing, process and system validation, concept development, design engineering, budget and procurement, program management, facility commissioning and software validation. As a result of its acquisition the firm will become part of Quintiles Consulting, which provides broad strategic consulting services throughout the product development and commercialization process.
"Regulatory commissioning and validation often are causes of delay in obtaining approval to manufacture from the Food and Drug Administration," said Jim Hamill, Executive Vice President of Quintiles Consulting. "Oak Grove has extensive experience in helping companies comply with the FDA's regulatory standards governing manufacturing. Oak Grove's compliance expertise, combined with Quintiles' industry-leading clinical research and commercialization services, can help bring products to market faster. That translates into real value for our customers and patients in need."
Oak Grove, which has about 50 employees, had been privately held. Quintiles has entered into employment agreements with Oak Grove's former president, Mitch Januszewski, and executive vice president Thomas Dzierozynski, who will continue to lead this new unit of Quintiles Consulting.
"As part of Quintiles, we'll have access to a significantly larger base of customers that could benefit from our services," Januszewski said. ``This transaction also gives us greater opportunity to address product manufacturing issues earlier in the development process. For customers, this should mean faster, more cost-effective compliance approval and production start-up."
Quintiles Transnational Corp. is the market leader in providing a full range of integrated product development and commercialization services to the pharmaceutical, biotechnology and medical device industries. Quintiles also provides healthcare policy consulting and health information management services to healthcare and governmental organizations worldwide. Quintiles is headquartered near Research Triangle Park, North Carolina. Quintiles operates through specialized work groups dedicated to meeting customers' individual needs and has more than 15,000 employees worldwide and offices in 30 countries.
For more information: Jim Hamill, Executive Vice President, Quintiles Consulting, P.O. Box 13979, Research Triangle Park, NC 27709-3979. Tel: 919-941-2888. Fax: 919-941-6258.