Regulatory areas on food and feed

  • 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
  • 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

medfiles from regulatory plan to submission

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
  • 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 liaisonmedfiles package labelling check for foods
  • Data searches and literature reviews, also systematic literature reviews

Food, feed and cosmetics  labels

  • Regulatory check ingredients
  • Writing and review of package labels for foods and food supplements
  • Writing and review of package labels for animal feeds
  • Writing and review of package labels for cosmetic products
      • EU legislation, national legislation: Nordic countries (Finland, Sweden, Norway, Denmark) 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, Norwegian, Danish and other languages