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FDA Warning Letter Response and Remediation

Our FDA warning letter response and remediation services include training and staff preparation, assistance with response to FDA 483 observations and warning letters and assistance with remediation planning and execution.

Responding to regulatory issues is not only good business practice, but many times it’s mandatory. The remediation, if any, is just as important. USDM Life Sciences will assess the regulatory requirements and current status for a company by utilizing its extensive background in all aspects of regulatory and compliance issues. We can find items where most companies will not be able to. The remediation aspect is covered through our array of subject matter experts with various areas of expertise, so you can be assured of getting the right consultant for the right situation.

Our staff includes former FDA investigators who can help your firm craft a clear and accurate response to technical inquiries for GxP reviewers as well as to warning letters and technical questions to FDA’s centers. Technical data can span from questions regarding particle size and morphology characteristics, microbiology, dissolution, stability, relative impurities, clinical and pre-clinical data to finished form product and have experienced professionals in scientific and other technical areas.

Examples include:

  • Regulatory Response: FDA, MHRA, EMA, other regulatory agencies
  • FDA Remediation Programs to address 483s, NOVs, Warning Letters, Consent Decrees
  • CMC Technical Inquiry response to CDER/CBER/CDRH Review Division