FDA REGULATORY SERVICES

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

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ABOUT THE FIRM
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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.

Proud Member of Medical Alley Association

CONTACT
  • 423 Main Street South
    Stillwater, MN - 55082
  • 612.382.7584
  • 651.430.7150
  • office@gardner.legal
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