Signal Detection & Literature Monitoring

Proactive signal detection and systematic literature monitoring are essential for identifying potential safety risks early and ensuring patient protection. At MedWatch Consulting, we provide structured processes and expert oversight to help organizations detect, evaluate, and act on safety signals in compliance with global regulatory standards.

Our services include routine signal management activities, statistical data reviews, and continuous monitoring of scientific and medical literature to capture relevant safety information. We align all processes with FDA, EMA, and ICH requirements, ensuring that no critical data is overlooked.

With our support, your organization gains a robust system for early risk identification and evidence-based decision-making, building confidence in both regulatory compliance and patient safety.

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ICSR processing & submission

ICSR processing & submission

We process and submit ICSRs accurately and on time to meet global PV requirements.

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Aggregate reporting (DSURs, PSURs)

Aggregate reporting (DSURs, PSURs)

We prepare DSURs and PSURs to deliver timely, compliant aggregate safety reporting.

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