• Review of product packaging and labeling to ensure all regulatory (FDA, FTC and CPSC) requirements are met

  • Guidance and assistance on compliance to Poison Prevention Packaging and CPSIA requirements

  • Advice and guidance on handling and/or reporting of adverse events

  • Advice and guidance on product recalls, including agency communications

  • Guidance and assistance on compliance to Good Manufacturing Practices

  • Daily monitoring of federal agencies and Federal Register with prompt notification to client of new regulatory initiatives

  • FDA Establishment Registration and Drug Listing Submissions

  • Preparation of Supplier Quality Agreements

  • Review and/or development of standard operating procedures pertaining to all items noted above

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