Aggregate safety reports written to GVP and ICH standards
PSUR, PBRER, DSUR and PADER writing services from a clinician led team serving India, MENA, Europe, and global markets.
Aggregate safety reports are recurring, deadline driven, and unforgiving of shortcuts. EvySaif writes Periodic Safety Update Reports (PSUR) and Periodic Benefit-Risk Evaluation Reports (PBRER) to ICH E2C(R2) and GVP Module VII, Development Safety Update Reports (DSUR) to ICH E2F, and Periodic Adverse Drug Experience Reports (PADER) for US requirements, for products at every lifecycle stage.
Our clinician led writers work from your safety database outputs, literature surveillance, and exposure data to produce reports whose benefit-risk evaluation is a genuine analysis rather than a template refill: signals are characterized, cumulative data are interpreted against the reference safety information, and conclusions are written to withstand assessor questions. The same team supports the surrounding documents, from signal evaluation reports to responses to health authority assessment comments, alongside our broader pharmacovigilance writing services.
What we deliver
PSUR / PBRER
Periodic reports to ICH E2C(R2) and EU GVP Module VII, aligned to the EURD list cycle, with benefit-risk evaluation grounded in the cumulative data.
DSUR
Annual development safety reports to ICH E2F covering ongoing clinical programs, with clear presentation of cumulative subject exposure and emerging safety findings.
PADER and national formats
US periodic adverse drug experience reports and national periodic formats for markets that retain them, prepared from the same validated data set.
Assessor responses
Structured responses to PRAC and national assessor comments, written with the clinical reasoning assessors are asking for.
Built to the standards that matter
Frequently asked questions
Can you work inside our safety templates and systems?
Yes. We write inside your document templates, follow your style guide and conventions, and work from the listings and tabulations your safety system produces.
How do you handle the recurring cycle?
We maintain a product level report history so each period builds on the last: standing sections stay consistent, and the new interval data receives the analytical attention, which shortens review cycles on every subsequent report.
Do you also write signal evaluation and risk management documents?
Yes, including signal evaluation reports, risk management plan sections, and safety narratives, so the aggregate report and its supporting documents tell one consistent story.