Pharmaceutical Product Risk Assessments

Assessing the potential risk a product might pose to patient safety is an iterative process that should continue throughout the product’s lifecycle:

  • Development – risk assessments can help inform the safety monitoring plan.

  • Preparing a New Drug Application – provide input supporting proposed specifications.

  • Post-approval Monitoring – Establishing surveillance programs for product quality-related events.

  • Manufacturing Process Changes – Adopting datamining paradigms to monitor post-change event reports.

  • For-cause Assessments – Manufacturing deviations or excursions including contaminants, decomposition, environmental stresses, atypical stability testing results.

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