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Home Our Services Regulatory services Food and nutrition services

Food and nutrition services

Medfiles’ Food and nutrition team offers expertise in regulatory positioning and finding the most suitable launch strategy for foods, food and feed ingredients. We take both the product characteristics and the marketing points of view like claims into account. The team has also extensive experience in submission of various dossiers: health claim, novel food, Generally Recognized as Safe (GRAS), New Dietary Ingredients (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 and food information provided to consumers. The team consists of regulatory, clinical, food science 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 (infant formulas, foods for special medical purposes)
  • Addition of vitamins and minerals
  • Food improvement agents (additives, enzymes, flavourings)
  • Chemical contaminants
  • NDI and GRAS notifications to FDA in the US
  • Feed materials, feed additives and medicated feeds

medfiles from regulatory plan to submission

Regulatory services provided

Framing of regulatory strategies

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

Evaluation of documentation for European Commission/EFSA and FDA submissions

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

Compilation of dossiers and submissions to European Commission/EFSA and FDA or national authorities

  • Preparation of dossiers or parts of dossiers
  • Dossier submissions
  • Authority liaison
  • medfiles package labelling check for foodsData searches and literature reviews

Regulatory compliance of food labels

  • Writing and review of package labels for foods, food supplements and feeds
  • Translations of labels into Finnish, Swedish and other languages
  • Regulatory compliance check according to EU regulatory framework
  • Regulatory compliance for national Nordic legislation
  • Checking the mandatory FIC requirements
  • Regulatory conformity of ingredients, descriptions and claims
  • Searching applicable nutrition and health claims for products