Setting up a regulatory strategy is not simple, but you can sum it up in 3 fundamental steps:
1. Define a Regulatory Intelligence plan, that is collecting as many data and information as possible from different sources (guidelines, Regulations, experts’ opinions) to create a regulatory overview as real and complete as possible.
2. Elaborate a Scientific Advice plan, that is drawing some conclusions as a result of the regulatory intelligence carried out and defining the interacting modes with the Regulatory Authorities by outlining the alternatives and therefore encourage a reasoned choice.
3. Write a Regulatory Strategy Document, that is the summary of all the activities carried out.