RESEARCH TRIANGLE PARK, N.C. - February 11, 2002 - Quintiles Consulting today announced the launch of MARKETREADY™, a comprehensive, step-by-step process to help manufacturers of medicines and medical devices meet regulatory standards in pre-approval inspections.
Pre-approval inspections are conducted by the Food and Drug Administration (FDA) as a part of its regular review of all product applications. MARKETREADY provides guidance to manufacturers in all key milestones including product development, process validation and regulatory inspection. The program also helps manufacturers manage issues that may result from prior regulatory actions associated with practices in laboratory and production settings.
"Delays in product launch can mean losses in revenue and market share," said Joseph Phillips, vice president, Pharmaceutical Services, Quintiles Consulting. "With MARKETREADY, our experts assist manufacturers in assessing, developing and implementing processes. This service helps assure an effective transition from R&D to commercial production." Phillips was formerly with the FDA, where he helped develop the pre-approval inspection strategy. The staff of Quintiles Consulting provides the benefit of years of practical experience and leadership in implementing solutions in both regulatory and manufacturing environments.
Ron Johnson, executive vice president, Quintiles Consulting said, "We estimate that the total current market potential for these kinds of consulting services is about $100 million. Because we see increased activity among emerging and established pharmaceutical and biotech companies, we are optimistic that the demand for these services will increase."
Quintiles Consulting is a commercialization unit of Quintiles Transnational Corp. (Nasdaq: QTRN). Quintiles Consulting provides regulatory, compliance and validation consulting services to pharmaceutical, biotechnology and medical device industries around the world. These services include assisting companies in preparing for FDA interactions, including inspections and resolution of enforcement actions; complying with good manufacturing practice, good clinical practice and quality system regulations; meeting process validation requirements and in bringing new medical devices to market.
Quintiles Transnational Corp. is the world's leading provider of information, technology and services to bring new medicines to patients faster and improve healthcare. Headquartered near Research Triangle Park, North Carolina, Quintiles Transnational is a member of the S&P 500 and Fortune 1000. For more information visit the company's Web site at www.quintiles.com.
Information in this press release contains "forward-looking statements" regarding Quintiles and Quintiles Consulting that involve risks and uncertainties that could cause actual results to differ materially, including without limitation, the risk that the market for our products and services will not grow as we expect, changes in trends in the pharmaceutical industry, and actual operating performance. Additional factors that could cause actual results to differ materially are discussed in the company's recent filings with the Securities and Exchange Commission, including, but not limited to its Annual Report on Form 10-K, its Form 8-Ks, and its other periodic reports, including Form 10-Qs.