Core competence

Early assessment

Official HAS or EMA/EUnetHTA early advice

• ca. 10-12 months
• MQΩ supports clients throughout the whole submission process

Post-official feedback: 

• Conclusion on a development plan that can be capitalized at time of launch through the minimization of risks & by selecting the optimal trade-offs between the different European HTA bodies and the regulatory body
• HTA forecast assessment (base and best case)

Mock Parallel/early Scientific Advice

• ca. 4 months
• Optimization of the phase III design from an HTA perspective (EU & US)
• Production of a briefing book is built with key regulatory and HTA questions
• Expert panels with former HTA members from selected jurisdictions
• Format: written feedback on briefing book and Advisory board to discuss key design questions & any regulatory and  HTA discrepancies
• Deliverable: Report with in-house strategic feedback (best compromise in-between jurisdictions & long-term  impact assessment)