Once you know the regulatory feasibility of bringing your product to market, you need a solid regulatory plan to follow.
Amgen provides three steps to regulatory planning & this depends on how far along you are in your product development:
1. Data audit - reviewing any existing data for compliance
2. Gap analysis - identify study & data gaps
3. Regulatory roadmap - A comprehensive regulatory strategy & a step-by-step breakdown of all the studies & data required to build your dossier, along with the study requirements, costings & timelines to market.
This regulatory plan provides everything you need to build a compliant dossier & improve your chances of regulatory success.
To find out more or to book a free consultation: