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)

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27 rue Blomet
75015 Paris
+33 (0)9 66 97 82 58