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  • About us

    About Clinigen

    A global pharmaceutical services partner working with pharma and biotechs to support access to medicines across the product lifecycle.

    Who we are
    Who we are
    • Our purpose and approach
    • Leadership team
    How we help
    • Pharmaceutical & biotech companies
    • Healthcare professionals
    • Patients
    Partner with us
    • Our lifecycle model
    Global presence
    • Asia, Pacific and Japan
    • Europe
    • South Africa
    • United Kingdom
    • United States
    Careers
    • Vacancies
    • Benefits
    • Culture
    • Diversity and inclusion
    • Our teams
    • Career FAQs
    • Our offices
    • Privacy notice - applicants
    Financial information
  • 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
    Product access
    SSI Strategy
    Leadership team
  • 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.

    Access services overview
    Pre-approval and Managed Access
    • Managed Access programs
    • Managed Access consulting
    Global partnering (licensed and unlicensed distribution)
    Exploitant services
    Leadership team
  • Insights

    Insights

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

    Explore our insights
    Insights blog
    Case studies
    Events
    Press releases
    In the media
Regional sites
  • language Australia
  • language France
  • language Germany
  • language Japan
  • language Korea
  • language South Africa
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logo-white.svg logo-green.svg Clinigen Direct
  • About us
    About us

    About Clinigen

    A global pharmaceutical services partner working with pharma and biotechs to support access to medicines across the product lifecycle.

    Who we are
    • Who we are
      Who we are

      Who we are

      • Who we are
      • Our purpose and approach
      • Leadership team
    • How we help
      How we help
      • How we help
      • Pharmaceutical & biotech companies
      • Healthcare professionals
      • Patients
    • Partner with us
      Partner with us
      • Partner with us
      • Our lifecycle model
    • Global presence
      Global presence

      Global presence

      • Global presence
      • Asia, Pacific and Japan
      • Europe
      • South Africa
      • United Kingdom
      • United States
    • Careers
      Careers

      Careers

      • Careers
      • Vacancies
      • Benefits
      • Culture
      • Diversity and inclusion
      • Our teams
      • Career FAQs
      • Our offices
      • Privacy notice - applicants
    • 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
    • SSI Strategy
    • 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.

    Access services overview
    • Pre-approval and Managed Access
      Pre-approval and Managed Access

      Pre-approval and Managed Access

      • Pre-approval and Managed Access
      • Managed Access programs
      • Managed Access consulting
    • Global partnering (licensed and unlicensed distribution)
    • Exploitant services
    • Leadership team
  • Insights
    Insights

    Insights

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

    Explore our insights
    • Insights blog
    • Case studies
    • Events
    • Press releases
    • In the media
Regional sites
Regional sites
  • language Australia
  • language France
  • language Germany
  • language Japan
  • language Korea
  • language South Africa

Our Products

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    Our global offices
    • Asia, Pacific and Japan
    • Europe
    • South Africa
    • United Kingdom
    • United States
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    Legal
    • Website Terms of Service
    • Cookies
    • Privacy policy
    • Privacy statement for PV data
    • UK Gender Pay Gap Report
    • Modern Slavery Statement
    • Consumer information obligations
    • Clinigen Terms and Conditions of Business (Sales)
    • Clinigen Terms and Conditions of Business (Purchases)
    • Tax strategy
    • Clinigen Integrity Line (Whistleblowing System)
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