Tim Philips, Consultant
Email tphilips@gardner.law
Mobile 715.821.8127
Tim Philips is a quality assurance and regulatory affairs professional with over 30 years of experience in commodities regulated by the U.S. Food & Drug Administration (FDA). He is an expert and instructor in FDA law / regulation, quality systems, inspections, evidence development, enforcement actions, and product recalls with an emphasis on post-market compliance of medical devices. Tim is an Adjunct Professor at the University of St. Thomas (St. Paul, MN) in the Regulatory Science Program in the School of Engineering.
350
Establishment inspections conducted or reviewed as an FDA Investigator and Compliance Officer
26
Marathons completed in 21 different states (including the Boston Marathon)
In a complicated and evolving regulatory landscape, one thing endures — the need for innovative, safe, and effective medical products. After a rewarding 32-year career with FDA, I am eager to use my experience in quality systems and regulatory affairs to help clients achieve their business goals and improve public health.
– Tim Philips, Consultant
Practice Areas:
- Regulatory
- Quality
- Enforcement
- Quality System (a.k.a. GMP) assessments, investigations, and training
- Resolving FDA Warning Letters, Untitled Letters, and “Form 483” Inspectional Observations
- FDA “Regulatory Meetings”, information requests, and inspections
- Product field actions (e.g., corrections/removals, recalls, safety alerts)
- Mitigation and remediation of FDA enforcement actions
- Mock FDA audits