Aggregate Reporting (DSURs, PSURs)

We provide end-to-end support for aggregate safety reports—DSURs and PSURs/PBRERs—covering planning, authoring, quality review, and submission in line with ICH E2F and ICH E2C(R2) expectations.

Our process includes defining scope and DLPs, consolidating data from clinical and safety databases, literature and signals, conducting medical review and benefit–risk evaluation, and preparing clear conclusions and risk minimization updates, with full editorial/QC checks.

We manage timelines and partner review cycles to ensure on-time, compliant submissions to regulators and stakeholders, maintaining complete traceability and an audit-ready document package.

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