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:
- Submission of SUSARs
- Preparation and submission of Annual Study Reports.
- Site support in LEC related activities.
- Literature Searches
- Periodic Safety Update Report (PSUR) submission
- Qualified Person Responsible for Pharmacovigilance (QPPV)