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    Reaching more patients, touching more lives.

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    • Decarbonising healthcare
    • Developing change makers
    • Leading with integrity
    • Recognition, participation and awards
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  • Lifecycle services

    Lifecycle services

    We offer the regulatory strategy services to support ex-US Access Programs

    Lifecycle services overview
    Regulatory strategy
    • Drug development consulting
    • Regulatory strategy & submissions
    • Marketing authorisation holding and maintenance
    • Regulatory and scientific writing
    • Regulatory Advisory Board
      • Regulatory Advisory Board team
    • Medical device consulting
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  • Clinical services

    Clinical services

    We accelerate your journey through clinical development so your product can reach more patients and touch more lives.

    Clinical services overview
    Clinical trial supplies
    • Packaging and labelling
    • Comparator sourcing
    • On-demand sourcing
    • Global storage and distribution
    • Clinical supply chain management
    • Returns, reconciliation and destruction
    • QP services
    • Controlled drug services
    • Specialty services
    Biological sample management
    • Biorepository services
    • Biological sample logistics
    • Biological sample collection kits
    eCEMS: Clinical trial supplies management platform
    Leadership team
  • Managed Access & global partnering

    Managed Access & global partnering

    Our unique combination of services enables quicker access to innovative medicines for patients in every corner of the globe.

    Global by design
    Pre-approval and Managed Access
    • Managed Access leadership team
    • Managed Access Programs
    • Managed Access Consulting
    Global partnering (licensed and unlicensed distribution)
    Regional partnerships
    Exploitant services
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    Insight

    The latest news, insights and resources for providing access to medicines.

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logo-white.svg logo-green.svg Clinigen Direct
  • About
    About

    Our Story

    Reaching more patients, touching more lives.

    Our mission
    • Why We Exist
    • How We Help
      How We Help
      • How We Help
      • Pharmaceutical & Biotech Companies
      • Healthcare Professionals
      • Patient Groups
      • Patients
    • Global Offices
      Global Offices

      Global Offices

      • Global Offices
      • Asia, Pacific and Japan
      • Europe
      • South Africa
      • United Kingdom
      • United States
    • Leadership Team
    • Careers
      Careers

      Careers

      • Careers
      • Vacancies
      • Benefits
      • Culture
      • Diversity and Inclusion
      • Our Teams
      • Career FAQs
      • Our Offices
      • Privacy Notice - Applicants
    • Sustainability
      Sustainability
      • Sustainability
      • Accelerating access
      • Decarbonising healthcare
      • Developing change makers
      • Leading with integrity
      • Recognition, participation and awards
      • Corporate policies, reports and data
    • Financial Information
  • Lifecycle services
    Lifecycle services

    Lifecycle services

    We offer the regulatory strategy services to support ex-US Access Programs

    Lifecycle services overview
    • Regulatory strategy
      Regulatory strategy

      Regulatory strategy

      • Regulatory strategy
      • Drug development consulting
      • Regulatory strategy & submissions
      • Marketing authorisation holding and maintenance
      • Regulatory and scientific writing
      • Regulatory Advisory Board
        • Regulatory Advisory Board
        • Regulatory Advisory Board
        • Regulatory Advisory Board team
      • Medical device consulting
    • Product access
    • Leadership team
  • Clinical services
    Clinical services

    Clinical services

    Clinical services

    We accelerate your journey through clinical development so your product can reach more patients and touch more lives.

    Clinical services overview
    • Clinical trial supplies
      Clinical trial supplies

      Clinical trial supplies

      • Clinical trial supplies
      • Packaging and labelling
      • Comparator sourcing
      • On-demand sourcing
      • Global storage and distribution
      • Clinical supply chain management
      • Returns, reconciliation and destruction
      • QP services
      • Controlled drug services
      • Specialty services
    • Biological sample management
      Biological sample management

      Biological sample management

      • Biological sample management
      • Biorepository services
      • Biological sample logistics
      • Biological sample collection kits
    • eCEMS: Clinical trial supplies management platform
    • Leadership team
  • Managed Access & global partnering
    Managed Access & global partnering

    Managed Access & global partnering

    Managed Access & global partnering

    Our unique combination of services enables quicker access to innovative medicines for patients in every corner of the globe.

    Global by design
    • Pre-approval and Managed Access
      Pre-approval and Managed Access

      Pre-approval and Managed Access

      • Pre-approval and Managed Access
      • Managed Access leadership team
      • Managed Access Programs
      • Managed Access Consulting
    • Global partnering (licensed and unlicensed distribution)
    • Regional partnerships
    • Exploitant services
    • Leadership Team
  • Insight
    Insight

    Insight

    The latest news, insights and resources for providing access to medicines.

    Insights
    • Insights Blog
    • Case Studies
    • Events
    • Press Releases
    • In the Media
Regional sites
Regional sites
  • language Australia
  • language France
  • language Germany
  • language Japan

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