X Pharma Plus efficiently manages Periodic Aggregate Safety Reporting, ensuring global regulatory compliance. Our services include customized template creation, report preparation, medical review, submission, and health authority query handling (RTQs) across both pre- and post-approval phases.
Aggregate Safety Reporting Services – Overview
Marketing Authorization Holders (MAHs) must periodically submit aggregate safety reports to Health Authorities (HAs) to ensure the safety and efficacy of their medicinal products.
These reports include both pre-approval and post-marketing submissions:
- Cumulative safety summaries for molecules under clinical development, including nonclinical and clinical trial safety data.
- Development Safety Update Report (DSUR): Harmonized annual safety reports across ICH regions, replacing ASRs and IND annual reports.
- Summaries of core safety information for marketed products.
- Includes PADERs, PBRERs/PSURs, Summary/Bridging Reports, Addendums, Safety Assessment Reports, ASRs, and Ad-hoc reports.
Strategic activities managed by X Pharma Plus include scheduling, resource allocation, classification, report preparation, medical review, submission, HA query handling, and compliance tracking.
Aggregate Safety Reporting Services
“Compilation and submission of periodic safety reports to evaluate cumulative safety data and ensure regulatory compliance.”