FDA Compliance Group LLC

Your solution to FDA compliance needs

FDA Compliance / Legal Services

Obtaining FDA approval and maintaining FDA compliance is a complex, ongoing process. Our FDA consultants are former FDA employees and industry experts – who have extensive regulatory experience. That means we understand the FDA agency and how to navigate its infrastructure.

We can assist you with all of your FDA compliance and legal issues, including:

FDA Strategy

FDA Technical Assistance

  • complaints / CAPA
  • MDRs (Medical Device Reporting)
  • S/AER (Serious / Adverse Event Reporting)
  • Reportable Food Registry
  • FDA recalls
  • SOP (Standard Operating Procedure)
  • GMP (Good Manufacturing Practice)
  • HACCP (Hazard Analysis and Critical Control Points)
  • management structure
  • design controls

FDA Food Industry

  • Food Safety Modernization Act
  • Reportable Food Registry
  • shell eggs
  • drinking water
  • medical foods
  • low acid / acidified foods

FDA Compliance Training

  • technical training (including medical device, drug, dietary supplements, GMP, HACCP, lab, sterility, and specification development)
  • FDA inspection
  • FDA law

FDA Import Support

  • FDA detentions
  • DWPE (Detention Without Physical Examination / automatic detention)

FDA Technical Support to Law Firms

  • GMP and audit support
  • remediation support
  • FDA submission
  • FDA application
  • FDA compliance

Our FDA compliance and consulting extends to all industries regulated by the FDA, including: medical device manufacturers, dietary supplement companies, pharmaceutical / drug companies, biotechnology companies, food producers, and tobacco companies.

For more information on FDA compliance and consulting services or to schedule a consultation, please contact us.