Pharmacovigilance

We understand the importance of the pharmacovigilance requirements for your product. Our experienced staff (including an in-house physician) are committed to on-time, high quality service. We can help you in your pharmacovigilance activities by offering a full range of services:

Pre-authorisation

  • Safety Management Plans (SMP)
  • Serious Adverse Event (SAE) processing
  • Suspected, Unexpected, Serious Adverse Reaction (SUSAR) submissions
  • Post-Authorisation Safety Study (PASS) & Drug Utilisation Study (DUS) support
  • Risk Management Plan (RMP) writing
  • Development Safety Update Report (DSUR) writing

Post-authoriation

  • Qualified Person for Pharmacovigilance (QPPV) & Deputy QPPV provision
  • Pharmacovigilance System Master File (PSMF) writing and maintenance
  • Safety Data Exchange Agreement (SDEA) writing
  • Adverse Drug Reaction (ADR) processing
  • Literature screening
  • Post-Authorisation Safety Study (PASS) & Drug Utilisation Study (DUS) support
  • Signal detection and assessment of Risk-Benefit ratio
  • Safety Review Meeting chair and contribution
  • Risk Management Plan (RMP) maintenance
  • Periodic Safety Update Report (PSUR) writing

Database & Processing

  • Pharmacovigilance database – E2B compliant
  • EudraVigilance setup & support
  • Article 57(2) maintenance (XEVMPD)

Support

  • Audits & Inspections
  • Pharmacovigilance training
  • Quality Management System (QMS) & Standard Operating Procedure (SOP) development
  • Regulatory intelligence updates

Interested in our service? Let's talk