REGULATORY

Stillwater MedTech Consulting can help you answer regulatory questions, make timely and effective regulatory submissions, and help ensure you receive regulatory approvals.

Experience sets us apart.

Our staff have diverse regulatory backgrounds including:

  • Serving as the top executive of the Regulatory function

  • Working at the FDA in the Office of Regulatory Affairs

  • Making submissions to the FDA under various pathways including, PMA, de novo, 510(k), 505(b)(2)s, IND, NDA, orphan drug, among others

  • Extensive experience negotiating with the FDA and making regulatory submissions

  • Answering a multitude of regulatory questions

We have experience with:

  • FDA Regulatory Submissions

  • Answering regulatory questions related to the Federal Food, Drug, and Cosmetic Act

  • Addressing and responding to FDA 483 observations

  • Device submissions: 510(k), PMA, Pre-IDE, de novo, Humanitarian Device Exemptions, Combination Products

  • Drug submissions: IND, Pre-IND, ANDA, Orphan Drug, 505(b)(2)

  • Pre-Submission meetings

  • Panel meetings

  • Negotiating clinical trials

  • Negotiating labeling

  • Modifications

  • MDRs and adverse event reporting

  • Form 2253 submissions

  • CE Marking

  • CER filings

  • CFR 10.75 Appeals

  • Citizen Petitions

  • Requests for Designation

  • Performing mock inspections

  • FDA meetings

  • Crisis management

  • Recall assessment, strategy and management

  • Part 806 corrections and removals

  • Health Hazard Evaluations

  • Letter To File drafting