Activities related to the development/regulatory strategy or clinical strategy are managed by the project manager who works closely with internal experts and a panel of external experts.
- The development plan making process :
- Selection of experts (Regulatory – Medical – Methodology) and other consultancy to tailor a solution according to your development goals
- Preparation and submission of a Scientific Advice to regulatory agencies
- The development plan declination :
- Budget and schedule by phase
- Providers assessment and selection