Cummins Strategy Partners
Strategic advisors to Pharma and Biotech for EU commercialisation
EU commercialisation support
Phase
CSP Support
Value Delievered
Pre-Launch and Market Assessment
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
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 Execution Support
• Coordinate affiliate setup, exploitant services, pricing & reimbursement submissions
• Manage distribution, patient support, and medical information programmes
Seamless transition from early access to full commercial supply
Post Launch Optimization
• Monitor pricing, access performance, patient uptake
• Advise on lifecycle management, label expansion, or post-approval evidence needs
Sustains market access and optimizes long-term value
• Evaluate EU market attractiveness
• Map regulatory and access pathways (EMA vs national)
• Identify early-access opportunities and potential for chargeable supply