• ICSR and Incident Report Processing
  • Pre-approval and Post-market Aggregate Report Preparation or Review

The Certus PV team provides comprehensive Individual Case Safety Report (ICSR) services including collection, data entry, MedDRA coding, medical assessment, and expedited reporting. Our expert team conducts searches of the published scientific and medical literature customized to your needs and obligations and performs full review.

The Certus PV team provides comprehensive Individual Case Safety Report (ICSR) services including collection, data entry, MedDRA coding, medical assessment, and expedited reporting.
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We also offer complete processing services for medical devices and cosmetics.

Our experienced PV team produces periodic aggregate reports in the ICH formats (DSURs, PSURs, PBRERs) and non-ICH formats (Canadian Annual Summary Reports and U.S. PADERs). We evaluate the benefit- risk balance of products, assess the need for changes and propose actions for further discussion with the regulatory agency.

Our experts also prepare Issue-Related Summary Reports for Clients who are requested to submit such reports to the regulatory agency.