RESEARCH TRIANGLE PARK, N.C. - Tuesday, December 2nd 2014 [ME NewsWire]
(BUSINESS WIRE) - Quintiles today announced a new offering that combines its industry-leading pharmacovigilance, regulatory dossier/label maintenance, benefit-risk management, and analytic expertise into one integrated solution. This solution will help biopharmaceutical companies better manage all activities required to maintain the licenses for their portfolio of marketed products.
Underpinned by a fully-integrated technology platform, the new offering, called Marketed Product Maintenance (MPM), will provide biopharmaceutical companies with greater data-driven insights on the benefit-risk profiles of their products. These enhanced insights will enable customers to identify potential product risks, fulfill increasingly complicated regulatory requirements and help them make better decisions about their marketed products. By using technology and subject matter expertise to connect the post-approval requirements and license maintenance processes more effectively and efficiently, biopharmaceutical companies can generate greater return on investment from their portfolio of established products by redeploying resources on prioritized, growth-oriented products.
“Within most biopharmaceutical companies, regulatory, safety maintenance and benefit-risk management functions could benefit from more interdependence,” said Paula Brown Stafford, president of Clinical Development at Quintiles. “Meanwhile, these companies are facing more complex safety and regulatory requirements, along with increasing budget constraints, making it increasingly difficult to achieve their regulatory obligations while improving the total cost of managing their established products. Integrating these functions through our innovative MPM solution will assist customers in maximizing the commercial value of their established products.”
These services will be delivered globally as an integrated and efficient turnkey solution, leveraging Quintiles’ extensive safety, regulatory, benefit-risk management research experience, as evidenced by:
Ninety-nine percent on-time compliance for approximately 1.5 million clinical, post-marketing, and device safety reports processed globally since 2009;
One hundred percent of approximately 1,500 electronic common technical documents (eCTDs) submitted to the EU, U.S. and Canada passed technical validation.
For more information about the MPM Solution, visit www.quintiles.com/MPM.
Quintiles (NYSE:Q), a Fortune 500 company, is the world’s largest provider of biopharmaceutical development and commercial outsourcing services. With a network of more than 32,000 employees conducting business in more than 100 countries, we helped develop or commercialize all of 2013’s top-100 best-selling drugs on the market. Quintiles applies the breadth and depth of our service offerings along with extensive therapeutic, scientific and analytics expertise to help our customers navigate an increasingly complex healthcare environment as they seek to improve efficiency and effectiveness in the delivery of better healthcare outcomes. To learn more about Quintiles, please visit www.quintiles.com.
Click here to subscribe to Mobile Alerts for Quintiles.