REGULATORY AFFAIRS SUPPORT

We support our customers with regulatory affairs questions related to antimicrobial materials and their intended applications.

We understand that antimicrobial functionality is not only a technical topic, but also a regulatory one. Depending on the material, application, market, and claim, different requirements may apply. This is why early regulatory assessment is an important part of a successful development process.

Our team helps customers understand which regulatory aspects may be relevant for their product, including material documentation, antimicrobial claims, test requirements, biocompatibility considerations, and the distinction between product protection and user protection claims.

We support our customers in preparing the technical basis needed for regulatory discussions, customer documentation, and validation planning. This may include selecting appropriate test strategies, aligning laboratory results with intended claims, and identifying the documentation required for further product development.