Ongoing monitoring, assessment, and reporting that keeps your product compliant long after approval.
Pharmacovigilance Support encompasses the ongoing monitoring, assessment, and reporting of adverse drug reactions and safety signals throughout a product's lifecycle.
Services typically include case processing, signal detection and management, periodic safety update reports (PSURs/PBRERs), risk management plans (RMPs), and literature surveillance — helping companies meet post-market safety obligations and maintain regulatory compliance globally.
Processing adverse event reports as they arise.
Identifying and managing emerging safety signals.
Preparing periodic safety update reports on schedule.
Maintaining a current, defensible RMP.
Case processing and signal detection workflows are established.
Adverse events are processed and safety signals evaluated.
PSURs and PBRERs are prepared and submitted on schedule.
The RMP is kept current as new safety data emerges.
Ongoing case processing and signal detection support.
Periodic safety update reports (PSURs/PBRERs) prepared on schedule.
A current, defensible risk management plan.
A dedicated point of contact for post-market safety.
Talk to our regulatory and scientific experts today.
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