Medfiles’ Food & Nutrition and Feed team offers expertise in regulatory positioning and launch strategy solutions for foods, and food ingredients, as well as animal feed ingredients. Our services cover existing food products and food and feed innovations from totally new sources, taking into account both product characteristics and marketing issues. Our expert team has extensive experience in working in these areas, and in the submission of various dossiers: food supplements; health claims and novel foods in the EU; Generally Recognized as Safe (GRAS); and New Dietary Ingredients (NDI) in the US.

Medfiles is happy to assist with all the aspects of food governance – “from farm to fork” – throughout entire food production chain to the labelling of end-products and food and feed information provided to consumers. The team consists of regulatory, clinical, food science and toxicological experts in the field and can provide a comprehensive overview of the various aspects of product research and development.

Food and feed regulatory areas covered

  • Ordinary foods and food ingredients
  • Food supplements
  • Nutrition and health claims
  • Novel foods
  • Foods for specific groups (e.g. infant formulas, foods for special medical purposes (FSMP))
  • Fortification with vitamins and minerals
  • Food improvement agents (additives, enzymes, flavourings)
  • Food Contact Materials (FCM)
  • Chemical contaminants of foods and feeds
  • New Dietary Ingredients (NDI) and ingredients Generally Recognized As Safe (GRAS) in the US
  • Animals feeds, feed materials, feed additives
  • Cosmetics

Regulatory services provided

Framing of regulatory strategies in the EU and USA.

  • Descriptions of regulatory framework
  • Regulatory positioning and regulatory route identification
  • Compiling regulatory strategy
  • New product development (NPD) for food and feed ingredients and products
  • Counselling on positioning of and strategies for borderline products (pharma vs. medical device vs. food)
  • Consultation requests for potential novel foods

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
  • Consultations concerning authority opinions, and local regulations and practices 

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
  • Data searches and literature reviews, also including systematic literature reviews

Food, feed and cosmetics labels

  • Regulatory check for ingredients
  • Writing and review of package labels for foods and food supplements
  • Writing and review of package labels for animal feed products
  • Writing and review of package labels for cosmetic products
  • EU legislation, national legislation: Nordic countries (Finland, Sweden, Norway, Denmark), Baltic countries (Estonia, Latvia, Lithuania) and USA
  • Mandatory and voluntary package and marketing texts including nutrition and health claims
  • Listing applicable nutrition and health claims for products
  • Translations of labels into Finnish, Swedish, Baltic (Estonian, Latvian, Lithuanian), Norwegian, Danish and other languages via regulanet® network 

Training, lectures and other services

  • Tailored training or lecture in any food/feed regulatory field
  • Acting as a food/food supplement/feed expert for our clients for a certain period (outsourced resource) or permanently

For more information please contact

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