Regulatory Affairs

Comprehensive coverage

Food supplements, medical devices, pharmaceuticals or perhaps a borderline product? It’s not always easy to separate product categories. Each category comes with its own different regulatory requirements. Our regulatory affairs department keeps its eye on the ball for you. These are our services at a glance:

• • Support in questions of borderlines (analysis of regulatory requirements, assessment of envisaged product claims and indications)
  • Checking marketability (provision and review of labelling and mandatory information on packaging, checking approvals, used amounts and the quality of ingredients contained, checking usable health claims)
  • Providing product documentation (raw material data, production data, analysis certificates, stability data) and, if required, carrying out notifications, declarations and applying for approvals
  • Further support after product introduction (such as with administrative objections, complaints, competitive processes, changes in light of new guidelines)