← Cases & Insights

Case Study

Regulatory Assessment for Registration of Antimicrobial Biocidal Product

Qudits investigated regulatory requirements, registration options, and costs for an innovative antimicrobial biocidal product across Switzerland, France, and Germany.

Situation

Biocidal applicability and regulatory requirements as well as costs and timelines for the registration of an innovative antimicrobial biocidal product had to be investigated, registration options evaluated and visualized into a clear management decision basis.

Solution

Evaluation of active substance identity and clarification of regulatory status of active substance(s) and biocidal product; summarization of national registration rules and requirements (including fees, data requirements, timelines, costs) in Switzerland and EU countries (FR, DE); development of a decision board with strategic recommendations for action.

Impact

Creation of a decision-making basis for the management on the further use and distribution of a new innovative product with antimicrobial properties within EU and Switzerland.

Qudits’ role: Project lead

Facts & Figures

  • 3 months
  • 2 consultants
  • 1 partner
Related service: Qualität & Compliance