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  • Medical Devices & Diagnostics

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  • Quintiles Clinical Trial

    Realize the full potential of your medical device despite the maze of regulatory and development challenges.

    The rapidly changing regulatory environment can sap your competitive edge. From strategic planning and regulatory consulting to managing regulatory processes and preparing submissions, our global experience across virtually all device types helps pave your path to market.

    Regulatory expertise and global footprint to support your medical device success

    • Regulatory experts with hundreds of years of combined experience, which includes working as US Food and Drug Administration (FDA) reviewers, as supervisors and managers at the FDA's Center for Devices and Radiological Health (CDRH), and with virtually every device review organization within the FDA
    • Medical device services across the globe, including Europe, Latin American and Asia Pacific, with a combination of industry veterans and ex-agency personnel

  • Perspectives on medical devices

  • Quintiles Clinical Trails

    Additional focus has been placed on clinical evaluations since changes in the Medical Devices Directive [“MDD”]1 have come into force in March 2010. Read brochure

  • Quintiles Clinical Trails

    Consulting thought leaders discuss some of the top reasons biopharmaceutical companies fail to make progress on the compliance maturity curve and offer expert advice on how these challenges can be best addressed.  Listen now