Aggregate Reporting

Aggregate safety reports synthesize the evolving benefit-risk picture and are core regulatory deliverables with firm deadlines. A late or weak PSUR, DSUR or PADER is both a compliance risk and a missed opportunity to tell the benefit-risk story well. PharmExpert authors these reports to a high standard — accurate, well-argued and delivered on schedule across your portfolio.

We manage the full process: planning data lock points and the reporting schedule, sourcing data, and assembling line listings and summary tabulations. Disciplined planning across a portfolio is what keeps multiple overlapping reporting clocks under control.

The heart of each report is the benefit-risk evaluation, and this is where medical-writing quality matters. We craft a clear, defensible narrative and conclusions, not a mechanical data dump — the difference between a report that reassures regulators and one that prompts questions.

Every report is kept consistent with the signal record, RMP and current product information, so your safety documents tell one coherent story. We track the calendar and deliver on time, whether for a single product or an entire portfolio.