Regulations, Documentation & Registrations

Regulatory compliance, adequate documentation and (if required) registration are essential to successful products. We would be pleased to handle these matters on your behalf.

Typical services that we offer include:

  • Implementing EU regulations (Cosmetic Product Regulation, Medical Device Regulation, Biocide Directive and Regulation, CPL, REACH);
  • Cosmetic safety assessments, product information files (PIFs), notification to authorities (EU);
  • Assuming the role of EU Responsible Person to support non-EU marketers of cosmetic products;
  • Ensuring medical device quality compliance (ISO 9001, cGMP, ISO 13485), product registrations (EU Class I).

Please contact us with any specific requests you may have.

 

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