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Pharmacovigilance

Pharmacovigilance

Our pharmacovigilance team delivers comprehensive safety solutions to meet the evolving global regulatory landscape. We support our partners from clinical development to post-marketing surveillance.

  • Case processing and adverse event reporting
  • Scientific literature review and signal detection
  • Aggregate report preparation (PSUR, PADER, DSUR)
  • Risk management planning and submission
  • Global compliance with ICH, EMA, MHRA, USFDA

By combining scientific insight with compliance expertise, we ensure patient safety and regulatory confidence throughout the lifecycle of your product.