Formulation

Formulation development according to :

    • Appropriate Regulatory conditions (Regulatory status, Specific countries, claims)
    • Health benefits and safety
    • Specific  requirements (galenic form, quality, price)

  • 1 Specifications book
    Preparation of a specification book containing scientific requirements (SAFETY/EFFICACY), marketing aspects (claims/wording), regulatory needs (COUNTRIES/CLAIM), organoleptic characteristics, galenic development, daily dosage, maximum cost price,…

  • 2 – Research, analysis and recommendation of ingredients
    Research, analysis, selection and recommendation of ingredients with active effects according to their scientific substantiation and regulatory compliance.

  • 3 – Theoretical Formulation

    • Development of a theoretical formulation, taking into account:

      • Appropriate efficacy and safety dosage of selected ingredients
      • Potential additional ingredients more likely to be identified and recognized by consumers
      • Other ingredients that may allow the use of Health Claims

    • Completion of a technical dossier presenting specifications, selected ingredients list, formulation, potential health claims, legal status.

  • 4 - Galenic development

    • Identification of the most adapted Contract Manufacturer depending on the galenic form.
    • Labs and pilot trial
    • Completion of a completed “batch file”

  • 5 - Scientific substantiation

    • Completion of a scientific file substantiating the efficacy and interest of the ingredients used for the targeted health application, with bibliographic reference

  • 6 - Regulatory authorization
    Validation of the authorization of the selected ingredients in accordance with specifications and selected dosages.

    • Support for label compliance.
    • Notification registration through authorities.

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