When patients have a life threatening or debilitating illness, and their physicians have exhausted current treatment options, there simply aren’t any available or 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 and biopharma companies with medicines that may help will often support access for these patients.
Access programs and unlicensed medicines
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
- 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 experts 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 biotech and pharma companies of all sizes to design programs which meet your global requirements. As a team of leading experts in access to medicines, we design strategies and programs to match your objectives and the patients’ need.
Our programs are powered by an understanding of need and delivered with compassion for patients. We understand the importance of your clinical development program, and ensure that any access program delivers for both the 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.
We are here to help you
Mark has significant experience in implementing global access programs and leads our Medicines Access unit.
EXECUTIVE VICE PRESIDENT,
With a background in practicing medicine, Maria oversees all activity to ensure that patient safety remains at the core of our operations.
CHIEF MEDICAL OFFICER
With a background in pharmacology and project management, Ruth leads the implementation of our pre-approval access programs.
Head of Project Management,
Industry expert in supply chain management. Annika leads our quality team and ensures best-in-class supply chain solutions for our clients.