Regulatory Consulting Services

Regulatory Consulting Services Image


We provide cost-efficient regulatory consulting services to companies in the Food and Beverage, Dietary Supplement, Cosmetic, and Homeopathic/OTC 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

cGMP Facility and Vendor Audits (Manufacturing, Warehousing and Distribution, Importing, Outsourcing) 
  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


Services Main Contact Form