PSUR Checklist


At SJ Pharma Consulting, LLC in Mendham, NJ, we provide our clients with a comprehensive checklist that is designed to support the review of a PSUR. Our checklist addresses the following PSUR sections
Title Page
Executive Summary
Table of Contents (Only After Draft Publication)
  • Section 1: Introduction
  • Section 2: Registration and Marketing Status
  • Section 3: Regulatory or Partner/Company Actions Taken for Safety Issues
  • Section 4: Changes to Safety Information
  • Section 5: Estimated Drug Exposure
  • Section 6: Presentation of Cases
  • Section 7: Studies
  • Section 8: Studies
  • Section 9: Overall Safety Evaluation
  • Section 10: Conclusion
  • Section 11: Appendices
To learn more about our PSUR checklist, don't hesitate to contact us today. Our team is glad to provide the information you need.