FDA Compliance Group LLC

Your solution to FDA compliance needs

FDA Regulatory Services

In order to stay in compliance with the FDA, your company needs to stay in compliance with all current FDA regulations, which can change quickly and substantially.

Our team of FDA consultants (all of whom are former FDA employees or have extensive industry experience) are well-versed in the latest FDA regulations and compliance issues.

We can assist you with, or train you on, all aspects of FDA regulatory requirements, including:

  • Medical Devices
    • 501(k) submissions (Premarket Notification)
    • PMA submissions (Premarket Approval)
    • IDE submissions (Investigational Device Exemption)
    • 513(g) submissions (Requests for Classification)
    • 520(g) submissions
  • Pharmaceuticals / Drugs
    • NDA submissions (New Drug Application)
    • ANDA submissions (Abbreviated New Drug Application)
    • IND submissions (Investigational New Drug Application)
  • Food
    • NDI notifications (New Dietary Ingredient)
    • GRAS determinations (Generally Recognized As Safe)
    • structure / function notifications
  • Tobacco reviews and submissions
  • Registration / listings
  • label reviews and required submissions
  • website reviews
  • imports
  • Part 11 compliance (electronic signatures)
  • R & D profile analysis
  • new product or technology evaluation and promotions
  • analytical and bioanalytical development, evaluation, and guidance
  • CMC stability profiling, evaluation, and guidance (Chemistry and Manufacturing)

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