Regulatory Issues

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Regulatory Compliance

Cosmetics

We provide all necessary documents for certification and notification issues

 Certificate of Manufacture
 Certificate of Free Sale
 Certificate of Analysis
 Material Safety Data Sheet
 PIF dossier according to regulation 1223/2009 on cosmetic products
 Toxicological profile of the ingredients
 CPNP Notification
 Responsible Person
 Implementation of ISO 9001:2015 & ISO 22716

Clinical Diagnostics

We provide all necessary documents for certification and notification issues

 European Representation
 Development Files
 CE marking
 Implementation of ISO 13485 & ISO 22716