Medicines Access

We are experts in the strategy, design, and implementation
of global pre-approval and unlicensed medicines access programs

Pre-approval and unlicensed medicines access programs

When patients have a life threatening or debilitating illness, their physicians have exhausted current treatment options or there simply aren’t any treatment options available or and they are unable to enter a clinical trial, mechanisms exist across the globe to enable access to pre-approval or unlicensed medicines. Healthcare professionals often seek to access these medicines for their patients and biopharmaceutical companies developing innovative medicines are increasingly making these medicines available to patients through pre-approval and unlicensed medicines access programs.

Consulting and delivery

We provide Medicines Access solutions for the biopharmaceutical industry in consulting, advising, designing, implementing, and delivering pre-approval and unlicensed medicines access programs. We support healthcare professionals to access pre-approval and unlicensed medicines for patients in need through these programs.

We help patients get access to treatment
  • Pre-approval programs
  • Unlicensed medicines access programs
  • Un-met medical need
  • Regulatory support
  • Healthcare professional support
We run access programs
  • Designed to meet the needs of medicine, company, and patients
  • Fully outsourced or in collaboration
  • Navigation of regulations and customs requirements
  • Personal service and project management
  • Global infrastructure and capabilities
Consulting services to biotechs and pharma
  • Strategies and policies
  • Education and insights
  • Feasibility and implementation
  • RWE evidence
  • Compliant communications
Supporting HCPs
  • Responsive key account management
  • Pre-approval and unlicensed medicines supply
  • Providing access globally
  • Supporting local regulatory and logistics requirements
  • Imap online access portal
  • Rapid, bespoke service

Our expert team have implemented over 200 access programs across all stages of the drug lifecycle, and supported healthcare professionals across the globe in accessing critical treatments for patients in need

We work with pharmaceutical and biotech companies of all sizes to design programs which meet global requirements.  As a team of leading experts in pre-approval and unlicensed access to medicines, we design strategies and programs to meet your objectives, the requirements for each specific product and the needs of the patients who are to be treated.

Our programs are powered by an understanding of specific need and delivered with compassion for patients. We understand the importance of your clinical development program, and ensure that any access program implemented delivers for both patients and physicians.

We have experience in the implementation of pre-approval access programs for medicines still in clinical development, as well as unlicensed medicines access programs providing access to medicines post first approval in countries where they are not commercially available.

Our Experts

We are here to help you


Mark has specialized in access programs for over 12 years and leads Medicines Access.

Mark Corbett



With over 20 years of industry experience, Stuart leads the consulting arm of our Medicines Access team.

Stuart Bell

Vice President Consulting,
Medicines Access


With 20 years experience in the pharmaceutical industry, Ruth leads the implementation of our pre-approval access programs.

Ruth Rostron

Head of Project Management,
Medicines Access


Kelly has 25 experience in regulatory affairs and quality assurance, 10 of which specializing in Medicines Access regulations

Kelly Fearn

Senior Director,
Head of Regulatory

We are here to help by providing vital advisory and practical support for the biopharmaceutical industry, healthcare professionals, and patient advocacy groups.

Clinical Trial Services

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Commercial Products

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