The Drug Safety Unit has extensive experience in managing all aspects of drug safety/pharmacovigilance services, from the drug development phase through to market authorization surveillance and pharmacovigilance.

Our services include:

Clinical studies

  • Submission of SUSARs
  • Preparation and submission of Annual Study Reports.
  • Site support in LEC related activities.

Post-marketing pharmacovigilance

  • Literature Searches
  • Periodic Safety Update Report (PSUR) submission
  • Qualified Person Responsible for Pharmacovigilance (QPPV)