General FDA Regulatory advice. The most effective FDA mock inspections using the identical tools used by the FDA, conducted by former US FDA Officers. We are experts in using the FDA regulatory manuals and compliance programs. We know the latest enforcement policy and the application of the policy on your product and company.
We work with different ex-FDA officers that have many years of experience in Medical Devices, Drugs, Foods, BIMO and most FDA programs. Let us help you meet and exceed those requirements before FDA shows up for inspection.
Customized US FDA Regulatory Program Training, Medical Devices, Drugs, and Foods. Informal coaching step by step helping your firm with FDA regulatory issues.
Remediation answering FDA-483s, Warning Letters, Untitled Letters.
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