Dossier Compilation

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Dossier Compilation



Based on the classification of food products and product type, Food and Food Supplements product compliance and registration requirements may vary from country to country. Few countries mandate registration or notification requirements, while few are merely compliance based, without the need of registration.

For registration-based countries, food products may be categorized as low-risk, medium-risk and high-risk foods or borderline products (of Drug-Food category). For those without any categorization also, registration is a must. Registration terminology may vary for each country where few countries call it as a simple notification or approval as well.

A Registration Dossier is a file/document that contains all the technical data (administrative, manufacturing, quality, control, nonclinical and clinical) of a product to be approved/registered/ marketed in a country. Any registration process requires a dossier or a technical file or set of technical documents, which for example, include a few or a combination of below mentioned:

  • Product formula, composition, ingredients and source data
  • Label and artwork
  • Claims and supporting data
  • Batch formula
  • Manufacturing process
  • Product specifications
  • Standard testing methods/method of analysis
  • Control procedure for active and inactive raw materials including the certificate of analysis of active ingredient(s) with its specifications
  • Control procedure for finished products
  • Stability data and storage conditions
  • Safety data
  • Nutritional analysis
  • Supplement and nutritional fact panel
  • Packaging material (food grade certificate)
  • Allergen, GMO type declarations
  • Plant certifications- HACCP, HALAL, Kosher, GMP, ISO

At Freyr, we cater various services for your technical documents/dossier compilation requirements. These include gap analysis, review and compilation of the documents required for product registration/notification as per respective Health Authority (HA) requirements. Freyr provides assistance in preparing the documents and suggesting any additional Food and Food Supplements safety report information and documentation required by the respective HA.

Freyr Expertise and Advantages


Freyr Expertise

  • Product registration/notification/approval documents’ gap analysis and compilation
  • Document review as per Health Authority (HA) requirements
  • Support for Food and Food Supplements/nutraceutical product dossier compilation and safety report preparation
  • Advice on additional mandatory documents
  • Food and Food Supplements/nutraceutical product compliance check
  • Recommending testing requirements, if any


Freyr Advantages

  • Cost-effective
  • End-to-end food product registration/notification and approval support
  • Qualified team of Regulatory experts with hands-on experience across all classification of food products like, health supplements, dietary supplements, nutraceuticals, health functional foods, health functional beverages, foods for special dietary use, etc.
  • Support for region-specific Regulatory complexities
  • Extensive partner network across the globe
  • Strong relationship with different health authorities