Medfiles USA team provides expertise in regulatory positioning and launch strategy solutions for foods, and food ingredients, as well as animal feed ingredients and now also cosmetics. Our services cover existing food and feed 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 working in these areas, and in the submission of various dossiers including dietary supplements, Generally Recognized As Safe (GRAS) and New Dietary Ingredients in the US as well as health claims and novel foods in the EU. For companies with an appetite to expand their market access to US and EU, our team has the regulatory expertise and the global reach to support non-drugs products full well.

Medfiles USA Service Menu:
Strategic Regulatory Development

  • Provide in-depth descriptions and clarifications around the current regulatory framework
  • Assist with regulatory positioning, regulatory route identification, and development of regulatory strategy for new ingredients
  • Consult on positioning and designing optimal strategies for borderline products (pharma vs. medical device vs. food) and requests for potential novel foods
  • New product development (NPD) for food and feed ingredients and food and feed products.

Documentation Assessment for Regulatory Submissions

  • Quantitative and qualitative evaluation of regulatory documentation and clinical plans
  • Gap analyses with respect to requirements
  • Consultation concerning authority opinions, local regulations and practices

Compilation of Dossiers & Submissions

  • Preparation either in part or in full of dossiers, e.g., novel food and health claim applications in the EU, GRAS dossiers (either self-affirmed or Notices to the FDA, NDI notifications
  • Submission of dossiers to FDA, European Commission/EFSA, or other national authorities
  • Authority liaison, meetings facilitation, and advisement
  • Data searches and literature reviews, standard or systematic

Food, Feed and Cosmetics Labels

  • Regulatory checks of ingredients
  • Writing and review of package labels for foods, dietary supplements, animal feed products or cosmetic products
  • US, EU and national legislation
  • Mandatory and voluntary package and marketing texts including nutrition, health and marketing claims

Other Services

  • Tailored training or lecture in food/feed/cosmetic regulatory field
  • Act as food/dietary supplement/feed expert for clients (temp or perm)