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FDA regulatory requirements for dietary supplements/nutritionals fall into a unique spectrum. Enhanced Compliance Inc. has experts in this complex arena available to consult with U.S. and foreign dietary supplement manufacturers in both bringing new products to market and in post-market reporting.

Our consultants can work with your team to develop compliant nutritionals manufacturing and reporting protocols, or we can review and improve upon existing systems. In addition, we can represent your interests in the case of non-compliance inspection findings to get your product-to-market timeline back on track.

  • Quality Management Systems to Meet FDA CGMP (Current Good Manufacturing Practices)
  • Electronic Record-Keeping Protocols Required for CFR Title 21 Part 11
  • Risk-Management Auditing with Compliance Action Plan Development
  • Guidance on Nutrition Labeling and Packaging
  • Review and Creation of Compliant Marketing/Promotional Materials
  • Import/Export Regulations Guidance
  • Staff Training in FDA Regulatory Regulations
  • Remediation Following Form 482: Notice of Inspection and Form 483: Inspection Report
Nutrition Facts Label representing the Nutritionals Industries
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