FDA Submissions and Applications Consulting

It takes a lot of time and resources to bring a new product to market in an FDA regulated industry, which is why it's vital that the FDA submission process goes as smoothly as possible.

Our team of former FDA employees and industry experts can assemble, review, and analyze your data, clinical studies, and AI-assisted submission materials to help ensure your FDA applications are accurate, complete, and submission-ready. We also review 510(k), DeNovo, pharmaceutical/ITC, clinical studies and good clinical practice, dietary supplement, food, and other FDA applications you've prepared with AI assistance, to help ensure accuracy, prior to FDA submission. Our FDA submission experts prepare appropriate and acceptable FDA submission-ready packages, making sure you have the best chance for receiving FDA approval.

Supported FDA Submissions

FDA Compliance Group is here to assist you with all of your FDA submission and application needs, including:

  • 510(k), DeNovo submissions for medical devices
  • Presubs for medical devices and clinical studies
  • PMA (Pre Market Approval) submissions for medical devices
  • IDE (Investigational Device Exemption) submissions for medical devices
  • 502g submissions for medical devices
  • 510k submissions for medical devices
  • Classification forms for medical devices
  • NDA (New Drug Application)
  • ANDA (Abbreviated New Drug Application)
  • NDI (New Dietary Ingredient) submissions
  • GRAS (Generally Regarded as Safe) affirmations
  • Structure / Function Claims for dietary supplements
  • CMC (Chemistry, Manufacturing, and Controls) submissions
  • Review of FDA applications and submissions written with the assistance of AI for accuracy prior to FDA submission

We are experienced with applications and submissions for all FDA regulated industries including medical devices, dietary supplements, pharmaceuticals/OTC, clinical trials, and food & tobacco. We also provide technical support for law firms that are assisting clients with FDA compliance.

Schedule your FDA submission consultation with the FDA Compliance Group today. For more information about FDA submissions and applications, call us at (303) 903-4801.

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