Unlicensed medicines

There is more pressure than ever before on pharmaceutical companies to provide access to their medicines outside the clinical and commercial environment to help patients with unmet medical needs. With more barriers to access, pharmaceutical and biotech companies are also coming under increasing pressure to maximise the potential of their asset throughout the product lifecycle.

Whilst complex and challenging, providing access to unlicensed, pre-approved medicines can form a critically important part of an access strategy.

Clinigen is the global leader in the specialist management of ethical, regulatory compliant and efficient solutions, helping pharmaceutical and biotech companies provide access to unlicensed medicines - outside the clinical and commercial setting - to address unmet patient need worldwide. We add insight, expertise and value at every stage of a medicine’s lifecycle, supporting pharmaceutical companies and healthcare professionals to provide the right medicine to the right patient at the right time.

Key facts


experience running over 250+ access programs


over 6,000 HCPs use Clinigen to access unlicensed medicines


countries where patient access provided

How we help

Clinigen is the global leader in the strategic planning, implementation and execution of early access (managed access) programs, enabling pharmaceutical and biotech companies to provide access to unavailable treatments for patients with unmet needs. For over 30 years, we have provided ethical, compliant and effective patient access solutions for hundreds of programs and thousands of medicines across almost every therapeutic area.

Our unrivalled expertise and experience enables:

  • Maximised patient access and asset value
  • Seamless transition from unlicensed to licensed stages
  • Avoidance of pitfalls of unlicensed medicines
  • Full project management and strategic guidance before, during and after programs
  • World-class service and a positive experience for healthcare professionals
  • An outsourced solution that meets your specific needs and ensures ethical and compliant access to your medicine

Our experience and expertise in providing access across all stages of the product lifecycle enable us to develop tailored solutions and support a seamless transition from unlicensed to licensed stages:

How we can help Healthcare Professionals