RESEARCH TRIANGLE PARK, N.C. – June 29, 2011 – Elevating compliance to achieve a strategic advantage – going beyond just meeting regulatory requirements for an innovative drug, biologic or medical device – allows biopharmaceutical companies to respond more rapidly to ever-changing conditions in the New Health, according to a new report from Consulting at Quintiles.
The Art of Compliance: Turning Compliance into Sustainable Business Advantage offers a fresh approach to help biopharmaceutical companies achieve quality and compliance improvements based on a “compliance maturity curve.” The compliance maturity curve moves from Stage 1, where the compliance model is essentially broken, through improvements in compliance and performance to Stage 4, where a sustainable, process-driven compliance system is in place.
“Best-in-class compliance can help biopharma firms achieve market differentiation by building a reputation for superior product and service quality and by avoiding the need for spending on reactive compliance,” said Robert A. Rhoades, Vice President, Quality and Compliance. “Sustainable compliance can profoundly affect the financial health of an enterprise.”
The report describes various approaches to compliance and illustrates how companies can move from a traditional approach to a more sustainable compliance framework that is efficient and fully integrated with key business processes. The analysis follows a spike in Food and Drug Administration enforcement activity, including record numbers of Warning Letters.
“Sustainable compliance is not just nirvana for the process gurus; it’s an imperative,” Rhoades said. “The best time to take action on compliance is before problems arise. Done poorly, it can mean interruption of supply to customers, long-term decline of a firm’s credibility and the ultimate demise of the business enterprise. Done well, it provides a competitive advantage, growth and financial health.”
About Consulting at Quintiles
Consulting at Quintiles delivers breakthrough thinking built on decades of industry experience. It helps customers optimize the clinical development process, access markets more effectively, maximize commercial performance over the lifecycle, mitigate regulatory compliance risks and validate and strengthen portfolio strategy. Consulting at Quintiles brings a critical element to engagements: fresh thinking built on a full lifecycle understanding of biopharma realities that draws on expertise from the Clinical, Commercial and Capital groups of Quintiles. For more information, please visit www.quintiles.com/consulting.
Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. The Quintiles network of more than 20,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics. Quintiles helps biopharmaceutical companies navigate risk and seize opportunities in an environment where change is constant. For more information, please visit www.quintiles.com.