EU roadmap for non-EU Companies

The European pharmaceutical market ranks among the largest globally, driven by relentless innovation and an aging population.

However, US companies encounter significant hurdles when entering the EU market, including the need to comply with centralized procedures as well as various national regulations.

Proactively considering EU-specific requirements in regulatory and market access strategies can significantly mitigate risks and streamline the path to market.

Engaging key stakeholders early in the process, including regulatory bodies and HTA authorities, can facilitate smoother approvals and a successful market entry.

RPN’s end-to-end support includes:

• Feasibility Analysis for SME Status: unlocking incentives specifically designed for Small-Medium Enterprises.
• Orphan Designation Application in the EU: obtaining special status and benefits for orphan drugs.
• PRIME eligibility request: benefitting from early and proactive support from EMA.
• CMC, Pre-clinical, and Clinical Gap Analysis: comparing EU and FDA requirements to ensure compliance.
• Landscape Assessment and EU Advisory Boards: gaining strategic insights and expert guidance.
• Regulatory/HTA Scientific Advice: streamlining your regulatory/HTA processes with expert advice.
• Marketing Authorization Application: defining and implementing successful approval strategies.
• Early Access feasibility: unlocking early access options in EU countries before regular market access.
• Centralized HTA Dossier (JCA) and Procedure: Navigate centralized HTA assessment efficiently.
• National HTA Dossier and Procedures: tailoring the company’s approach for individual Pricing & Reimbursement processes in EU countries.
• Coordinated Launch readiness strategy.