FDA Regulatory Submissions and Quality Management System.

Gardner Law can help you with making timely and effective regulatory submissions to the FDA, and other regulatory agencies, to help ensure appropriate approvals, notifications and filings.  The firm can also assist you with meeting your Quality Management System obligations.

FDA Regulatory Submissions and Quality Management System services include:
  • Providing medical device companies counsel on FDA regulations under the provisions and implementing regulations of the Federal Food, Drug, and Cosmetic Act
  • Assisting with Quality Management System, administration, audits; and helping to facilitate the CAPA process in response to FDA 483 observations
  • Assisting with the submission of 510(k)s, PMAs, Pre-IDEs, de novos, Humanitarian Device Exemptions, Combination Products
  • Providing strategic advice relating to INDs, Pre-INDs, ANDAs, Orphan Drugs, 505(b)(2)s
  • Pre-Submission meetings, Panel meetings, Negotiating clinical trials, Negotiating labeling, Modifications
  • Making FDA subsmissions, such as assisting with MDRs, adverse event reporting, Form 2253 submissions, and 21 C.F.R. 101.93 Structure/Function claim submissions
  • CE Marking and CER filings
  • Appeals and 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
Gardner Law Logo

Gardner Law specializes in laws and regulations that govern the development and commercialization of pharmaceuticals and medical technologies. The firm provides practical and responsive counsel to company leaders navigating the regulatory minefield which they face today.

  • 423 Main Street South
    Stillwater, MN 55082
  • 612.382.7584
  • 651.430.7150
  • office@gardner.law
Privacy Settings
We use cookies to enhance your experience while using our website. If you are using our Services via a browser you can restrict, block or remove cookies through your web browser settings. We also use content and scripts from third parties that may use tracking technologies. You can selectively provide your consent below to allow such third party embeds. For complete information about the cookies we use, data we collect and how we process them, please check our Privacy Policy
Consent to display content from Youtube
Consent to display content from Vimeo
Google Maps
Consent to display content from Google