Achieve market entry and scaling through global regulatory clearance and commercial partnership strategy. Highly customised support to secure commercial revenue and reimbursement across target markets, including Europe, the US, Japan, South Korea, China, Australia, and Canada. The support also provides strategic early implementation planning (starting at TRL 4) to ensure R&D processes generate market-proofed evidence necessary for subsequent HTA and global regulatory submissions. Usual duration is 6-12 months, delivered by specialists in Health Technology Assessment (HTA) and Global Regulatory Affairs. 
Activities include: 
• Execution-level assembly and submission of the final Technical Filing dossier, including specialized HTAR submissions.
• Full Health Technology Assessment (HTA) dossier development • Facilitated access to the provider’s network of larger BioPharma and MedTech companies seeking co-development and distribution deals.
• Support also covers Post-Market Surveillance (PMS) planning to ensure sustained regulatory compliance in international territories.
Implementation is rolling, utilising specialised consultancy and strategic matchmaking services. 
 

Benefits for EIC beneficiaries in i) spinout/startup, and ii) scale-up: 

The service facilitates the creation of the economic evidence package required to secure pricing and reimbursement. It ensures that the final regulatory and economic submissions meet the complex and varying demands of major international authorities. It accelerates scaling by providing direct support for partner identification and strategic deal execution necessary for international distribution. 
The expected outcome is market authorisation in key global territories, a clear reimbursement pathway, and finalized commercial partnership agreements for scale-up. 
Designed for EIC Transition and EIC Accelerator innovators (dedicated in-house or external experts, via online or hybrid models).