PSUR CHECKLIST

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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.