Ceo/Co-Founder
CurrentREJIMUS is a preeminent regulatory strategy and management consultancy empowering companies from around the world to make the best business decisions in quality and regulatory compliance with innovative solutions throughout the supply chains of the Food & Beverage, Dietary Supplement, Cosmetic and OTC/Homeopathic sectors. We are behind many of the leading brands, often from the beginning...many you may know, many more you will never know, because that is how we work. We excel at getting companies out of quality/compliance trouble by properly and fully resolving operational and systemic non-compliance issues impacting their bottom line or legal standing, developing and implementing sound regulatory strategies and documentation in the US, improving value chains, and ensuring compliance with major retailer seller requirements.Consulting expertise in the following:- Expert Witness and Litigation Consulting (for Regulatory, Quality, Packaging, Counterfeit Products, Claims, Contaminations, Recalls, Sales and related business practices)- GRAS Self-determinations (or w/ FDA Notification) & New Dietary Ingredient (NDI) Notifications and Re-submissions- Complete resolution of FDA Warning Letter's and Form 483's through to Close Out- FSMA, HACCP/HARPC, and FSVPs- Logistical studies, transportation safety, and sanitation studies- Business Strategy Planning and Transition Management for Quality and Compliance Operations- USDA Level 2 Registrations, Permit Holder and Import/Export Support and USDA Label Submissions- GMP Auditing (auditing, qualification or investigations)- Ingredient and Product Label Reviews, Claims Substantiation and Dossiers- Regulatory Scale-up Planning and Due Diligence for Products/Acquisitions- Product Importation and Exportation Strategy Development and Support- Quality Program Optimization & Troubleshooting
