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    A-pharmaconsult and Cosmetics

    July 6th 2023

    As a specialist in Quality and Regulatory Affairs, A-pharmaconsult can provide a full range of quality assurance (QA) and Regulatory Affairs (RA) services for the development, writing of dossier and notification of cosmetic products.

    A-pharmaconsult Cosmetic services draw on the accumulated knowledge and expertise of the A-pharmaconsult team of professionals highly versed in all relevant scientific, documentation, and regulatory disciplines with their in-depth experience in securing cosmetic approvals and bringing products to market.

    Cosmetic portfolio

    A-pharmaconsult offers a full range of cosmetic consulting services. These include:

    • QA/RA Evaluation:  A-pharmaconsult can assist with QA and RA advice plus development assistance to comply with quality and regulatory requirements. It can further assist clients in implementing or updating a comprehensive Quality Management System to comply with ISO 22716 guidelines.
    • Product Evaluation: this includes detailed advice on all the various tests that a cosmetic product must pass to comply with international regulatory guidelines and confirm they do not pose any risk to human health and whose results must form part of the final product dossier for market approval. These tests include:
      • Stability studies that measure the products against effects of aging, transport, and prolonged storage, as well as challenge testing against possible contamination by various germs and bacteria.
      • Safety studies for risks such as ocular tolerance, skin tolerance, etc.
      • Product Efficacy Studies to prove effectiveness of a cosmetic product for all its claims, including laboratory ex-vivo skin testing, clinical or instrumental testing.
    • Labelling: writing of product labelling is a further area of specialized expertise with all cosmetic and personal care product labelling required to follow detailed specifications and parameters, including ingredients lists that align with INCI (International Nomenclature for Cosmetic Ingredients) in the EU Regulations.
    • Promotion: Evaluation of promotional and marketing material to ensure full compliance with such standards as Cosmetic Products Regulation (EC) No 1223/2009 and Commission Regulation (EU) No 655/2013 on Common Criteria for Claims that impose specific requirements such as conformance to Common Criteria, legal compliance, and standards such as truthful, supported by evidence, honest, fair and allow informed decision-making by consumers.
    • Dossier preparation: A-pharmaconsult can help clients prepare complete product dossiers (Product Information File) for Cosmetic products, including Safety reports (Part A & B), to ensure full compliance with current EU regulations, including full writing services.
    • Regulatory Notification: once all product evaluation is complete, A-pharmaconsult can assist clients in finalizing the cosmetic dossier, ready for submission, such as the EU CPNP (Cosmetic Products Notification Portal) mechanism for the registration of cosmetic products. This will include designation of a Responsible Person (RP), ensuring all mandatory data is present and correctly formatted, timely adjustment in case of product changes and variations, with provision for maintenance and timely adjustment for subsequent product updates such as reformulation or label updates.


    Click on A-pharmaconsult Quality Assurance Services  for further information.


    Regulatory Affairs Services for the Pharmaceutical and Medical Device industries


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