EXPERT GUIDANCE EVERY STEP OF THE WAY

Dietary ingredients for use in dietary supplements can either be old, pre-DSHEA, grandfathered dietary ingredients (ODI) or New Dietary Ingredients depending on whether they were marketed and sold in interstate commerce prior to October 15, 1994. Our regulatory experts will determine whether your dietary ingredient is old or new.

NDI requirements are highly detailed, requiring an expert in NDI identity (chemistry) and safety (toxicology). Our team of regulatory experts, led by co-author of FDA’s NDI draft guidance for New Dietary Ingredient Notification and former FDA Branch Chief for Dietary Supplement Regulation Implementation, will provide you with a customized, all-in-one solution for successfully meeting NDI compliance.

• Strategy for filing an NDI notification
• Technical review of identity specifications and GAP analysis of toxicology data
  
• Recommendation for any pre-clinical safety studies (animal toxicology)
  
• Direct correspondence with FDA throughout the process and facilitation of a Pre-Notification meeting to ensure a successful submission
  
• Writing a comprehensive NDI Notification to meet federal regulatory requirement
• Organization of all identity and safety informations.
  
• Organization of raw data
  
• Full copies of all cited references
  
• Drafting of written narratives