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  • Regulatory Affairs

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  • Quintiles Clinical Trial

    As global regulatory requirements keep evolving, we’re here to help you increase your chances of regulatory approval.

    Quintiles global regulatory team includes over 1200 professionals based in more than 65 countries around the world, to help you navigate regulatory requirements throughout your product’s development lifecycle.

    Comprehensive expertise and capacity to help you gain regulatory approval

    • Marketing Applications - Global and regional MAA/NDA/BLA submissions; authoring and publishing (MAA/NDA/BLA, IND and other dossiers); Regulatory project management of dossiers; Dossier gap analyses; CMC, clinical and nonclinical; OMP and ODD. Learn more
    • Regulatory Maintenance/Lifecycle Support - License extensions, maintenance and renewals; Compliance; Due diligence; Regulatory writing support; Clinical and commercial linkage; Portfolio Optimization
    • Regulatory Strategic Advice - Clinical and regulatory program strategy; global regulatory roadmaps capturing regional considerations; Scientific advice: pre-submission, EOP2, CHMP, National Agencies; Pediatric plans in EU and US and multi-country filing strategy; Combination products, Biomarkers, Targeted therapies.

  • Pharma regulatory expertise to maximize your product success

  • Quintiles Clinical Trails

    Chapter excerpt from Risky Business: Managing the Quality of America's Medicines Read more

  • Quintiles Clinical Trails

    How Do You Manage the Health of Your Clinical Development Processes and Effectively Measure Performance, Control Risk, and Demonstrate Value? Read fact sheet