SERVICES
We provide cost-efficient regulatory consulting services to companies in the Food and Beverage, Dietary Supplement, Animal Feed, Cosmetic or Homeopathic industries at every stage of their respective supply chains. Quality Control and Regulatory procedures need to be developed, implemented and optimized as part of a comprehensive cGMP Quality System required by law, inclusive of establishing appropriate labeling before entering the marketplace.
Best Compliance Practices are the principles we’ve developed to ensure the right systems are in place and that they are aligned with your business goals, including your Regulatory Management Practices, Facility Design and Product Development Strategy. All projects are managed with very high degree professionalism, exceptional business ethics and an important sense of urgency. Guidance and expertise are useless without action, and REJIMUS works with you to reach the final steps of implementing and resolve quicker to fully maximize fruits of your labor.
Regulatory Consulting Services
• FDA Regulatory Consulting and FDA Compliance
• FDA Inspection Support and Response Planning
• Quality Systems Design & Implementation
• Technical Documentation Development (e.g. SOP’s, FDS, IDS)
• Product and Ingredient Risk Evaluations
• FSMA, Food Safety Plans, FSVP, HACCP to HARPC Conversions, Food Defense Plans and Exemptions
• Project Management & Contract Service Contract Negotiation
• Novel Ingredient Submissions (GRAS Dossiers and NDI Notifications)
• Labeling, Claims Substantiation and Marketing Content Review
Organizational Compliance Services
• Gap Analysis, Quality System Optimization, Loss Investigations
• Supply Chain Optimization, Import Detention Support and Relief
• Market Research and Customer Intelligence Research
• Reduced Ingredient Testing Strategies for Raw Materials and Finished Products
• Regulatory Market Evaluations
• Accreditation Planning, GMP Auditing and Inspection Support
• Quality Program Optimization and Restructuring Support
• Adverse Event Reporting Management
• Brand Reputation Support, Social Media Monitoring, Crisis Mitigation
Expert Support Services
• Litigation Consulting & Expert Witness
• M&A Support, Due Diligence
• Adulteration & Counterfeit Investigations