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
- 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