Food and nutrition services

Medfiles’ Food and nutrition team offers expertise in regulatory positioning and finding the most suitable launch strategy for foods and food ingredients taking into account the product characteristics both from the compositional and marketing points of view. The team has also extensive experience in submission of dossiers (health claims, novel foods, substantial equivalence, GRAS, NDI).

Medfiles is happy to assist with all the aspects of food governance – ‘from farm to fork’ – throughout the whole food production chain to the labelling of end-products (food information to consumers). The team consists of regulatory, clinical and toxicological experts in the field and has hence a comprehensive overview of the various aspects of product research and development.

Regulatory areas

  • Ordinary foods and food ingredients
  • Food supplements
  • Nutrition and health claims
  • Novel foods and genetically modified organisms (GMO)
  • Foods for specific groups (Foods for special medical/nutritional purposes) 
  • Addition of vitamins and minerals
  • Food improvement agents (additives, enzymes, flavourings)
  • Chemical contaminants
  • New Dietary Ingredients (NDI) and Generally Recognized As Safe (GRAS) notifications to FDA in the US

Regulatory services provided

  • Framing of regulatory strategies
    • • Descriptions of regulatory framework
    • • Regulatory positioning
    • • Regulatory route identification
    • • New product development (NDP) for a functional food product
    • • Counselling on positioning of and strategies for borderline products
    • • Requests for classification decisions

  • Evaluation of documentation for EFSA/FDA submissions
    • • Expert evaluation on amount & quality of documentation
    • • Gap analysis with respect to the requirements
    • • Regulatory and clinical plans
    • • Preparation of guidelines or reports on technical requirements as laid down in the legislation
    • • Authority consultations

  • Compilation of dossiers and submissions to EFSA/FDA or national authorities
    • • Preparation of dossiers or parts of dossiers
    • • Dossier submissions
    • • Authority liaison
    • • Data searches and literature reviews

  • Writing, review and translation of product labels
    • • Writing and review of package labels of foods and food supplements
      in the context of the regulatory environment in certain countries (Nordic countries, UK, eg.)
    • • Checking the ingredient lists and nutrition and health claims from regulatory point of view
    • • Searching applicable nutrition and health claims for products
    • • Translations of labels into Finnish, Swedish and other languages

Foodfiles services 

We have complemented our clinical research and regulatory affairs services for pharmaceutical and medical device companies with research and registration services for food and nutrition products. We continue the services provided earlier by Foodfiles Ltd. Services in food and nutrition and so-called non-drugs products strengthen our position significantly in the interface of medicinal products and food products.

Support from a plan to a successful submission

For more information please contact

Senior Regulatory Affairs Expert Essi Sarkkinen