FDA Compliance
Boyce Consulting has helped numerous companies comply with FDA regulations and compliance programs, especially in critical situations involving FDA-483 observations, Warning Letters, recalls, correction and removals and FDA inspections. We are experts at developing systemic corrective action plans...
FDA Training
Boyce Consulting utilizes one-on-one personalized service and custom training to ensure that you will be self-sufficient. Our proven track record in developing and training firms in all aspects of the quality system regulation, process validation, test method validation, premarket notification...
FDA Auditing
Boyce Consulting will provide FDA-mock audits for you or more specialized gap analyses that meet your needs. Our team includes an ex-FDA Regional Medical Device Specialist who was the Expert Medical Device Investigator for the FDA Southwest Region. We also have personnel on our team who have had 35...
Process and Test Method Validation
We work with FDA as an outside QSR expert witness on a periodic basis and are involved with FDA/Industry coalitions, workshops and alliances. We have provided QSR and process validation training to FDA and the Texas State Department of Health. Our involvement insures that your company has the most...
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