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NDI Notification, GRAS Submission - REJIMUS


NDI and GRAS   - REJIMUS provides strategic phased approach to conducting cost-effective feasibility, and efficient evaluations and dossier assembly services for New Dietary Ingredient Notifications (NDIN) and Generally Recognized As Safe (GRAS) Notifications. NDIN – New Dietary Ingredient (NDI) Notifications Do you have a New Dietary Ingredient to file with the FDA? Are you sure you need to file an NDI or could your product be considered an Old Dietary Ingredient or ODI? Does the FDA prefer an electronic NDI submission? What are the NDI Notification (NDIN) requirements? There are some exceptions to know about. We can assist in the review, preparation and submission of your NDI with greater success. Electronic New Dietary Ingredient Notification filing services include: • Reviewing the historical use and safety of the ingredient • Literature reviews and analysis of all scientific data, protocols and supporting documentation • Electronic NDI packet preparation and submission to FDA with Response Support • Dedicated Project Management Platform with Client side access