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Results for: Regulatory & Quality - Regulatory

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  • Sustainable Compliance Begins with a Strong Foundation

    Brochure — 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.

  • Quintiles Names Rick Sax New Head of Integrated Clinical Services

    Press Release — May 23, 2011 – Quintiles announced the appointment of Frederic “Rick” Sax as Senior Vice President and Global Head of its Integrated Clinical Services division.rograms.

  • Clinical Endpoint Committees

    White Paper — February 22, 2011
    As regulatory boards are expecting more from clinical endpoint committees, what guidance can you follow? This white paper sets forth current best practice for CECs.

  • 25 Years of Regulation - and Still Failing - Risky Business, Chapter 4

    Hear from the Experts — February 2, 2011
    Chapter Excerpt from Risky Business: Managing the Quality of America’s Medicines Chapter four identifies two simple principles needed for the improvement of quality management in pharmaceuticals today: managing consistency and maintaining responsiveness.

  • Responding to FDA Enforcement

    Brochure — 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

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

  • Scaling Up for Safety: How to Gain Efficiencies without Sacrificing Quality

    Case Study — September 16, 2010
    Read how Quintiles set-up a complete pharmacovigilance operation in a developing region in only six months for a leading pharma company.

  • Safety Strategy & Optimization

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

  • Managing Pharmacovigilance as a Business

    White Paper — July 28, 2010
    The three steps required to develop a strategic approach to global capacity management.

  • Communication Strategies for Risk Minimization

    Hear from the Experts — July 12, 2010
    In the US, the Food and Drug Administration (FDA) approves pharmaceutical products based upon the results of adequate, wellcontrolled clinical studies demonstrating that each product

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