The Responsible Person Compliance Pack

Are you an aspiring cosmetic brand owner in the EU and the UK, with no Regulatory/Compliance background, and no budget to hire a Responsible Person? 

Welcome! 

This was created for you! 

What does it contain?

A complete guide explaining the regulations in a way that it make sense for non-regulators, the sections are:

  • Responsible Person;
  • Stability Testing;
  • Challenge Testing;
  • Cosmetic Product Safety Report (CPSR);
  • Product Information File (PIF);
  • Good Manufacturing Practices (GMP);
  • Labelling; 
  • Notification Portals;
  • Cosmetovigilance.

Templates:

    1. Animal Testing Declaration Template
    2. Batch Manufacturing Record Template;
    3. Cosmetovigilance Logbook Template;
    4. GMP Audit Checklist Template;
    5. GMP Compliance Declaration Template; 
    6. Label Compliance Audit Template;
    7. Manufacturing Method Template;
    8. Product Information File (PIF) Template;
    9. Product Recall Procedures Template;
    10. Supplier Verification Checklist Template.

    The pack also comes with a one hour regulatory Q&A session.

    Who is behind the Compliance Pack? 

    Adiato has had the opportunity to work in Regulatory Affairs since 2016, beginning her experience with the Portuguese Regulatory Body, Infarmed.

    Adiato moved to the UK in 2017, and since then she has worked with Pharmaceutical Products, Medical Devices, Biocides, Food Supplements, Traditional Herbal Remedies, and Cosmetic Products, all in the Regulatory and Quality fields. Since 2020, she has been also  working as a Cosmetic Safety Assessor.

    In her current role af Group55, as the Regulatory Affairs and Product Safety Manager, Adiato works with cosmetics, household products and pet care products.

    Because certain products have different classifications in different markets, Adiato is also dealing with OTC Pharmaceutical Products, for markets outside the EU/UK.

    Before becoming a Regulatory Affairs Professional, Adiato worked in Hospital and Community Pharmacies, mainly as a drug dispenser for prescribed and OTC medicines, and dermato-cosmetics products. 

    For professional enquiries regarding regulatory services, manufacturing, or collaborations, please get in touch.

    .