Pharmacovigilance

Our pharmacovigilance team of experts can help you with all aspects to manage and monitor the safety aspects of your product or device to meet the required regulations. Services offered include:

  • Qualified Person for Pharmacovigilance
  • Pharmacovigilance Quality System preparation and management
  • Good Pharmacovigilance Practice auditing
  • Post marketing case processing management including EudraVigilance reporting
  • Signal detection
  • Global and local 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
  • Pharmacovigilance pre and post-marketing project management services

Clients & Testimonials