FDA Compliance

Label Reading

 

FDA COMPLIANCE

REJIMUS helps companies in the Food and Animal Feed, Dietary Supplement, Cosmetic and Homeopathic industries 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 the 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 closeout investigations and adverse events, we have the scalability to meet the most demanding of deadlines.

Compliance Services include:

  Regulatory Compliance 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

If your industry is supported by us and were interested in our compliance services, please contact us via the contact information at the bottom of this page. We look forward to working with you and providing solutions to help keep your products compliant with their respective regulations.