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