Confidence Beyond Compliance

Our experienced scientific writing and pharmacovigilance teams can support aggregate reporting and safety writing for all stages of the product life cycle, including summary of product characteristics, Reference safety information, Safety Update Report, Periodic Benefit-Risk Evaluation Reports among others.

We can provide complete support on aggregate reports -like SPC, ASR, RSI, PSUR, PADER and PBRER- from maintaining your global reporting calendar, to collating information from all your pertinent departments, writing safety reports and medical review of the prepared reports, to submitting the finalized document to the regulator.