Medial HUB

Preparation of a cosmetic product dossier and testing

Full support in conducting laboratory tests

Why is a dossier important?

Preparing a dossier for a cosmetic product (Product Information File, PIF) is a key step in ensuring that a cosmetic product complies with the requirements of the Technical Regulation

THE DOSSIER CONTAINS

  • Product information

  • Manufacturing methods

  • Test results and safety assessments

  • Proof of product effectiveness

The Product Information File (PIF) consists of

  • Product description

    Includes detailed product composition and intended use

  • Cosmetic product safety report

    Describes product safety, including physical and chemical properties, microbiological quality, analysis of conditions of use and effects on consumers

    Part A: Includes a detailed analysis of the composition, physical and chemical properties, microbiological quality, conditions of use, and potential risks

    Part B: A qualified expert conducts a safety assessment, taking into account possible interactions between ingredients, specific assessments, and necessary research. This report is a mandatory element of the PIF

  • Description of production methods

    Ensures that production processes comply with GMP standards

  • GMP compliance statement

    Confirms that the production process complies with Good Manufacturing Practice (GMP) standards

  • Product efficacy confirmation

    Includes research results confirming the efficacy of the product

  • Information on animal testing

    If such tests have been conducted, they must also be indicated in the PIF

Support in developing claims

We assist in preparing claims for product labeling:

  • Provide support in organizing additional tests

  • Prepare the necessary reports for inclusion in the dossier

Medical HUB
and its specialists have the necessary qualifications and education to prepare documentation for cosmetic products

We provide full support in conducting laboratory tests, such as physical and chemical analyses, microbiological studies, testing for resistance to microbial contamination and the effectiveness of preservatives (Challenge Test), as well as other necessary tests depending on the type of product

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