PV Services

Aggregate Reports Development:

Quartica provides services to manage the end to end aggregate reporting process from planning, development and review of deliverables to submission to the health authority. Our team of experts can provide you with the right expertise for the development and submission of the following aggregate reports:

  • DSUR: Development Safety Update Report
  • IND Annual Safety report
  • Orphan Drug Designation Annual Report
  • PADER: Periodic Drug Adverse experience Report
  • PSUR: Periodic Safety Update Reports
  • PSUR: Periodic Safety Update Reports
  • SBR: Summary Bridging Report
  • ACO: Addendum to Clinical Overview
Risk Management Plans:

We also provide expertise in the planning, development and review of Drug Safety Risk Management deliverables. These deliverables include:

  • Risk Management Plans (RMP)
  • PV Plans
  • Risk Evaluation and Mitigation Strategies (REMS)
  • Others