ICSR Processing & Submission

Accurate and timely management of Individual Case Safety Reports (ICSRs) is at the heart of pharmacovigilance (PV). At MedWatch Consulting, we provide end-to-end support for ICSR processing, quality control, and regulatory submissions, ensuring compliance with global reporting requirements.

Whether you need just client review (medical review) of cases processed by your PV vendor or complete processing, we can support you. Our services cover the full lifecycle of safety case handling — from case intake and triage, through data entry, coding, medical review, and quality checks, to on-time submissions in accordance with FDA, EMA, and ICH guidelines. We also support database reconciliation and oversight to maintain consistency and accuracy across systems.

With our expertise, you can be confident that all safety data is handled with integrity, efficiency, and regulatory compliance, reducing risk and ensuring patient protection at every stage.

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