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  • Sustainable Compliance Begins with a Strong Foundation

    December 8, 2011
    The urgency of a problem often entices people to quickly focus on finding a solution and repairing the problem in order to immediately remedy the situation.

  • Clinical Evaluation Medical Devices

    October 6, 2011
    A Clinical Evaluation Report (CER) is a living document required for all classes of new and existing products within the EU, detailing the clinical evaluation of a product throughout its life-cycle. Additional focus has been placed on clinical evaluations since changes in the Medical Devices Directive [“MDD”]1 have come into force in March 2010. A renewed focus by Notified Bodies on clinical evaluations, against the updated legislation, has led to a number of audit observations against manufacturers with regard to CER’s containing insufficient clinical data, or manufacturers not holding product CER’s.

  • Clinical – Smarter Trials, Accelerated Outcomes

    February 16, 2011
    Quintiles will work with you to plan and execute the smartest clinical trials and post-marketing studies, informed by a holistic view of strategic, operational, regulatory and marketplace issues.

  • Proven Precision

    February 2, 2011
    Quintiles brings together – under a dedicated project manager – incredibly talented regulatory strategists, medical writers, biostatisticians, and medical, publishing and clinical pharmacology specialists who work closely together to design and implement efficient, effective submissions from beginning to end.

  • Responding to FDA Enforcement

    October 5, 2010
    As the FDA ratchets up its enforcement actions, pharmaceutical and medical device companies are turning to Quintiles. Learn what differentiates our consulting solutions.

  • Reinventing Safety

    September 22, 2010
    When you integrate all your safety information, you can make better decisions, navigate regulatory hurdles and get to market faster.

  • Safety Strategy & Optimization

    September 14, 2010
    Learn how to enable your safety group to become a value-added contributor throughout the product lifecycle.

  • The New Health Clinical Brochure

    August 31, 2010
    Japanese version available for download.

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