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European Commercialisation Support 

Helping Pharma and Biotech Companies succeed in Europe 

The Path to Commercialisation

Strategy & Market Entry 
Pre Launch and Market assessment 
  • Evaluate EU market attractiveness 

  • Map regulatory and access pathways (EMA vs national)

  • Identify early-access opportunities and potential for chargeable supply

De-risks entry and prioritizes markets for focused investment

Early Access Enablement 
  • Design and manage Early Access / Named Patient Programmes (EAP, CUP,NPP)

  • Secure regulatory, ethical and pricing compliance 

  • Partner with local distributors  as required

Accelerates time to first patient and builds real-world data pre-approval

Evidence & Launch Optimisation 

Commercial Entry Planning 

  • Develop go-to-market plan (direct vs partner model)

  • Conduct partner/distributor identification due diligence

  • Support selection of pharmacovigilance, logistics, and medical partners

Provides low-risk, scalable route to EU commercialization

Real World Evidence Generation
  • Build data capture frameworks during EAPs

  • Liaise with payers, HTA bodies, and KOLs to align data generation with future pricing needs

Supports reimbursement negotiations and value demonstration

Launch & Post launch Support 
Launch Execution Support 
  • Coordinate affiliate setup, exploitent services, pricing & reimbursement submissions 

  • Manage distribution, patient support, and medical information programmes 

Seamless transition from early access to full commercial supply 

Post Launch Optimisation
  • Monitor pricing, access performance, and patient uptake 

  • Advise on life cycle management, label expansion, or other post approval needs 

Sustain market access and optimise long term value 

Belmont Suite Paragon Business Park, 

Horwich,

Bolton, 

BL6 6HG

United Kingdom

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Company number: 16797603

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