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  • Regulatory Compliance & Quality Management

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  • Quintiles Clinical Trial

    As regulators get tougher on enforcement, a proactive approach to quality and regulatory compliance can ensure sustained success.

    To meet today’s heightened demands, prevention is key. Our consulting team – an unmatched combination of former FDA/EMA officials and industry experts –helps biopharma, medical device and biotech firms across the world develop effective regulatory strategies and strengthen quality systems to create competitive advantage.

    Integrated regulatory compliance and quality management yield lasting benefits

    • Regulatory strategy – integrated solutions based on global and local expertise in 60+ countries
    • GCP, GLP, GMP and cGMP compliance and risk mitigation
    • Quality system design and optimization
    • Regulatory compliance remediation – track record of successful resolution of Warning Letters and establishing foundations for sustained compliance

  • Expertise in regulatory compliance & quality

  • Quintiles Clinical Trails

    Robert A. Rhoades, explains why biopharmaceutical companies can no longer afford to take a traditional compliance approach in a heightened regulatory environment. Read article

  • Quintiles Clinical Trails

    An integrated approach to process improvements and compliance remediation yields lasting benefits. Read brochure