Pharmacovigilance

WE GUIDE YOU THROUGH THE COMPLEX FIELD OF PHARMACOVIGILANCE, KEEPING YOU ORGANIZED AND UP TO DATE ON THE LATEST LEGAL REQUIREMENTS.

Pharmacovigilance

Our pharmacovigilance team helps you manage and monitor all safety aspects of your product or device so that it meets the required regulations. Our services include:

  • An EEA-qualified pharmacovigilance specialist
  • Pharmacovigilance quality system preparation and management
  • Good pharmacovigilance practice auditing
  • Post-marketing case processing management, including EudraVigilance reporting
  • Signal detection
  • Local and global literature reviews
  • Safety database management
  • Periodic safety update report preparation
  • Risk management plan preparation
  • Clinical trial pharmacovigilance services, including preparation of development safety update reports and case processing
  • Pre- and post-marketing pharmacovigilance project management


Have a question concerning Pharmacovigilance? Contact us