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EAPs are complicated. They are affected by numerous variables – not just regulatory jurisdictions, but also how they link to asset development and commercialization plans.

Our consultancy team can help you decide if an EAP is right for your asset, find the optimal timing, understand the regulatory structure, and integrate your EAP with RWD and commercialisation.

Our consultancy team brings together experience in pharmaceutical commercialization, international regulatory law, and pharmacy – domestically and internationally. We’ll work with you to develop the best solution for each potential therapy.

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Physicians want to do the best for their patients and often ask for access to innovative new therapies.

Team experienced in

  • Launch marketing
  • International pharmaceutical law
  • GxP regulations and implementation
  • International pharmacy
  • Pharmaceutical development
  • Health economics
  • Physician and HCP training and engagement
  • Patient and charity engagement

Typical projects

Typically, our team works with functions across your pharma biotech company, providing insight into:

  • Whether an EAP is right for your therapy/company
  • Integration into further development including real world data collection
  • Feasibility studies by country, region and globally
  • Preparation of business cases
  • Development of EAP policies

Our consulting leads

Josh Cocklin

A legal adviser by training and leading regulatory and medical ethics expert within the UK and EU. He brings a rigorous legal and analytical mind to all the issues.

Robert Donnell

A 25-year veteran of the pharma industry who has worked in commercial and supply chain functions. He brings the knowledge of integration and hands on experience in international EAP.

Kirti Patel

A qualified pharmacist with a focus on international pharmacy, Kirti combines deep knowledge of practice and regulation with a patient-centric approach.

The team has worked on numerous consulting projects across regulatory jurisdictions, therapy areas, and innovative companies. They’re also supported by an expert team from across Smartway.

Talk to the team