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REJIMUS is a preeminent regulatory consulting firm that helps companies globally in the Homeopathic, Food and Dietary Supplement industries with cost-effective and efficient filing services for New Dietary Ingredient Notifications (NDIN) and Generally Recognized as Safe (GRAS) Notifications.

We specialize in FDA Compliance ConsultingQuality Development ServicesSocial Media MonitoringDue DiligenceNDI and GRAS Notifications and Business Resource Services. Whether you are a start-up company focused on getting your first product to market and need to implement a quality system from scratch or you are a large established organization that needs to optimize and reduce risks and operating costs in regulatory and quality, we can enable you to achieve your goals efficiently.

Draft Guidance for Industry: New Dietary Ingredient Notifications

New Dietary Ingredient Notification Process

Do you have a New Dietary Ingredient (NDI) to file with the FDA? Are you sure you need to file an NDI? There are some exceptions to know about. Ingredient Identity can assist in the review, preparation and submission of your NDI with greater success. Typical turn-around times are 6 to 8 weeks for ingredient packages that have complete data and documentation available for review.

Key support for New Dietary Ingredients:

  • Reviewing the historical use and safety of the ingredient
  • Literature reviews and analysis of all scientific data, protocols and supporting documentation
  • NDI packet preparation and submission to FDA
  • Submission Response Support

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