REJIMUS helps Food and Animal Feed, Dietary Supplement, Cosmetic and Homeopathic companies achieve and maintain compliance with the FDA, FTC or other applicable regulatory agencies. Our team has expertise in manufacturing and production facility design, litigation consulting, analytical testing, GMP facility auditing, Quality System Optimization, Label Reviews and Claims Development/Substantiation. Additionally, our custom built web-based project management system allows us to track all work requests, deadlines and deliverables across multiple departments or client locations worldwide to support the most demanding of complex quality and regulatory compliance programs with precision and scalability.
483 Form Observations and Warning Letters
We provide consulting for FTC actions, FDA Inspection, Form 483’s and Warning Letter responses as well as GMP compliance planning for 21 CFR Part 111, 110 and 101, as well as budgeting and guidance for restructuring of quality and regulatory operations. Whether we take the lead support of an FDA inspection to ensure future compliance including the hand-on writing of standard operating procedures (SOPs) and specifications, or close out investigations and adverse events, we have the scalability to meet the most demanding of deadlines.
Areas of support include:
• Dietary Supplement Consulting
• FDA Response Letters, CAPA Planning, Facility and Vendor GMP Audits
• Claim Substantiation, Website Content and Claims Reviews
• Product Development and Analytical Testing Strategy Support
• Quality Program Optimization and Gap Analysis
• Compliance Operations Planning & Implementation
• Formulation Data Sheets (FDS) and Ingredient Data Sheets (IDS)
• Quality Agreement for Laboratories, Manufacturers and Distributors