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Regulatory Intelligence

Track regulatory developments and contextualize them within the life sciences industry.

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Our Regulatory Services

Stay ahead of regulatory changes with intelligence and expertise

Regulatory Monitoring

Monitor recent regulatory developments with policy implications including ICH Q8, Q9, Q10, Q11, Q12, Q13, Q14, and EU GMP Annex 1.

Key Features

  • ICH guideline tracking (Q8-Q14)
  • EU GMP Annex monitoring
  • Quality Metrics trends
  • Quality Culture developments

Benefits

  • Stay ahead of changes
  • Policy insight
  • Proactive compliance
  • Strategic planning
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Regulatory Monitoring

Quality Intelligence™

Our proprietary Quality Intelligence™ tool enables clients to compare recalls and observations against industry benchmarks, identify underlying causes, and assess severity relative to historical data.

Key Features

  • Recall comparison against industry
  • Observation analysis
  • Underlying cause identification
  • Severity assessment

Benefits

  • Industry benchmarking
  • Root cause insight
  • Risk prioritization
  • Data-driven decisions
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Quality Intelligence™

Need Regulatory Guidance?

Let's discuss how our regulatory intelligence can help you stay ahead of global requirements.