Professional

Find the essential services your business needs to thrive, while creating and preserving an inspired, dynamic, and productive workforce.

  • G&L Healthcare Advisors is a globally recognized provider of Integrated R&D Solutions, covering non-clinical, Clinical, Regulatory Affairs, and Quality Assurance consulting services in Pharmaceuticals, Biologics, and Cell & Gene Therapy. We help our clients achieve their business objectives by guiding proof of concept and IND enabling programs, optimizing drug candidate potential & asset valuation, obtaining positive FDA and EU Agency feedback, and securing global regulatory approval for IND and CTA clinical trial conduct, all the way through to product approval and launch.

    Our innovative solutions and services support clients at all stages of development to deliver meaningful change for the better.

    We provide strategic and tactical support and guidance at every stage of product development and commercialization to minimize time to approval and maximize cost-effectiveness.

    • Due Diligence and Program Assessment
    • Gap Analysis
    • Regulatory Roadmaps Assessments and Strategy
    • Regulatory and Competitor Intelligence
    • IND, CTA, BLA, NDA, MAA
    • FDA Meetings, EU and Global Scientific Advice
    • Chemistry, Manufacturing and Controls
    • Medical and Scientific Writing
    • Non-Clinical Strategy and Study Implementation
    • Clinical, Biomarker, and CDx strategy and Operations
    • Product Launch Services
  • Contact

    Jerrold Loo
    Director of Business Development          
    908.460.9901
    [email protected]

    Richard Edmunds

    VP of Regulatory Affairs          
    917.655.0244
    [email protected]
           
    4660 La Jolla Village Drive
    San Diego, CA 92121

    www.gandlhealth.com


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