Pharmacovigilance & Device Vigilance




Pharmacovigilance & Device Vigilance

SAPIO Health Care Solutions provides comprehensive pharmacovigilance and medical device vigilance services to support the ongoing safety, regulatory compliance, and lifecycle management of medicinal products and medical devices. Our team works closely with pharmaceutical companies, biotechnology organizations, and medical device manufacturers to establish robust safety surveillance systems that meet global regulatory requirements.

Our Services

Pharmacovigilance

  • Individual Case Safety Report (ICSR) processing
  • Adverse Event (AE) management
  • Serious Adverse Event (SAE) reporting
  • Signal detection and management
  • Aggregate safety reporting (PSUR, PBRER, DSUR)
  • Risk Management Plans (RMP)
  • Literature surveillance
  • Safety database support
  • Medical review and quality control

Device Vigilance (Materiovigilance)

  • Medical device incident reporting
  • Complaint handling and investigation
  • Post-market surveillance (PMS)
  • Post-market clinical follow-up (PMCF)
  • Field Safety Corrective Actions (FSCA)
  • Field Safety Notices (FSN)
  • Trend reporting and signal evaluation
  • Risk assessment and CAPA support
  • Regulatory reporting to global health authorities
  • Vigilance system development and compliance consulting

Our integrated vigilance solutions help clients identify potential safety issues early, maintain regulatory compliance, protect patients, and strengthen the overall safety and performance of healthcare products throughout their lifecycle.

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