Clinical Strategy

Starting with a blank sheet? We help you develop your clinical strategy world-wide, an essential planning support to Strategic Management of product development contributing to refined predictability of market access efforts needed:

  • Early determination of clinical development plan for global market access
  • Optimization – use of global data wherever possible – save costs and time to market!
  • Establish timelines and budgets
  • Review early strategies with Notified bodies or Regulatory Authorities – improved visibility/predictability of the strategy
  • Elaboration of the clinical development plan stages
  • Prepare and conduct US-FDA pre-submission meetings
  • Prepare and submit US-FDA breakthrough device dossiers
Contact us for a free half-hour consultation