LAW FIRMS & LEGAL PROFESSIONALS
For law firms that specialize in the Food, Animal Feed, Dietary Supplement, Cosmetic or Homeopathic industries, we have highly experienced regulatory and scientific professionals on staff to support cases related to quality or regulatory matters. We have one of the most thorough documentation and reporting practices that is standard to our business to support litigation matters involving regulatory actions citing claim substantiation, adulteration matters, purported breach of contract, non-compliance or counterfeit issues, injunctions and consent decrees under attorney oversight, product recalls, sales losses, marketing, and much more.
We provide law firms and/or in-house counsel with litigation consulting expertise in all areas of Regulatory Affairs, Quality Assurance, Quality Control, Product Complaints, Formulation and Safety within the specific industries we serve. Specific areas supported include scientific record keeping and facility auditing, formula investigations, marketing claims, off-label marketing reviews, contamination or adulteration issues and counterfeit products.
REJIMUS provides Litigation Consulting and Expert Witness services for matters involving Food or Food Ingredients, Animal Feed, Dietary Supplements, Dietary Ingredients, Cosmetics, Packaging, Homeopathic products and Medical Foods.
• Operational compliance investigations, documentation, auditing and training
• Compliance strategy and agency response(s): FDA, DOJ, FTC, USDA or other governing regulatory agencies
• Establishing Content, Use and Structure/Function Claims
• Label Misrepresentation or Adulterations/Mis-branding
• Breach of Contract or IP infringement support
• Regulatory Guidances & Interpretation
• Consumer Fraud or Adverse Events
• Expert Opinion
REJIMUS helps Food, Dietary Supplement, Cosmetic and Homeopathic companies achieve and maintain FTC and FDA compliance and resolve issues that have escalated to a Department of Justicee (DOJ) legal action. Our team has expertise in manufacturing and production, litigation support, analytical testing, GMP auditing, supply chain qualification, label claims and technical marketing for natural products. Additionally, our custom build web-based project management system that allows us to track all work, deadlines and deliverables across multiple departments or locations worldwide to support the most demanding of complex regulatory 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, 117 (formerly 110) and 101, as well as budgeting and guidance for restructuring of quality and regulatory operations. Whether we take the lead in an FDA response to ensure compliance including the hand-on writing of the response, the standard operating procedures (SOPs), specifications, labeling rework or the close out investigations of 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
• Compliance Remediation Plan Execution and Management/Reporting