REJIMUS is a preeminent regulatory consulting firm that helps companies globally in the Homeopathic, Food and Dietary Supplement industries improve and ensure the overall quality and regulatory compliance of their products with the applicable GMP regulations such as CFR 21 Part 111, Part 110 and/or Part 101.
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 Regulations for Dietary Supplement GMP Compliance ( 21 CFR Part 111 )
TITLE 21–FOOD AND DRUGS CHAPTER I–FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B–FOOD FOR HUMAN CONSUMPTION
PART 111 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
Business models supported:
- Contract manufacturer, Toll manufacturer, Private Label Manufacturer, Co-packer
- Retailers (online and storefront)
- Own-label Distributors, Contract Storage, Contract Distributors
- Direct Response and Online Marketers (for MLM’s, Network Marketers, Affiliates, IBO’s, Independent Distributor, etc.)
- Ingredient Manufacturers and Suppliers
- Specialty Events Promotion, Event Management and Marketing/Advertising Companies in the Food, Dietary, Bodybuilding and Sport Nutrition sectors.
Quality and Regulatory Services include:
- Regulatory consulting for FTC Actions, FDA Inspections, Form 483′s and Warning Letter responses
- GMP compliance planning and training
- Strategic budgeting and guidance for restructuring of quality and regulatory operations
- Writing, review and/or optimizing standard operating protocols (SOPs) and specifications for raw materials and finished products
- Technical and analytical data review data, testing procedures, study protocols, or close-out investigations
- Support for managing products complaints and adverse events