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Quality Management and Regulatory Compliance

We can help your business to:

  • Audit and mock-inspect your operations for quality and regulatory compliance
  • Respond to regulatory communications, warning letters
  • Train staff to work to GMP and prepare for inspections
  • Generate validation documentation

No biopharmaceutical company can afford an expense such as non-compliance, consequences can be having a product withdrawn from the market or having a high-profile approval delayed. Setbacks associated with routine agency inspections, as well as more serious Warning Letters are costly and often result in approval delays, product recalls, harm to reputation, and adverse impact on shareholder value. VPA’s QMRC experts can help you build a sustainably compliant operation.

Meet our practice leads