FDA Regulatory Services

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

Our team of FDA consultants are former FDA employees or have extensive industry experience. They stay current on all the latest FDA regulations and compliance issues.

FDA Compliance Group offers FDA regulatory services to assist or train you and your staff 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 / OTC
    • 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 and function notifications
  • FSVP/HACCP
  • MoCRA
  • Tobacco reviews and submissions
  • Registration and 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)

Need help with FDA regulatory services and submissions? Contact us to schedule a consultation.

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