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 Generally Recognized as Safe (GRAS) Notifications and New Dietary Ingredient Notifications (NDIN).
We specialize in FDA Compliance Consulting, Quality Development Services, Social Media Monitoring, Due Diligence, NDI 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.
FDA Guidelines and GRAS Notifications
For a Self-affirmed GRAS Notification or an Expert Panel to review a GRAS application dossier, we can assist with the development, management and submission to the FDA, from start to finish.
Key support for GRAS Notifications:
- Assessing ingredient development and regulatory strategies
- Literature reviews and research inclusive of all scientific data, protocols and supporting documentation – Phase I
- Toxicological study and data reviews – Phase I
- GRAS dossier preparation for either Self-affirmation or Expert Panel Review (including Panel Assembly and Moderation) – Phase II
- GRAS notification submission to the FDA and Response Support – Phase II