4. Regulatory strategy and impact on product development

Identifying and analyzing regulatory difficulties and risks upstream of product development is essential. The result is the regulatory strategy for bringing the product to market, a strategy which, right from the design phase, makes it possible to identify possible claims and requirements, having an impact on product development. Determining regulatory status is crucial, as it determines :

• possible claims, and the level of evidence provided to support them;

• product composition ;

• regulatory and administrative constraints with which the company must comply (file, notification, compulsory information, etc.);

• the tests to be implemented.