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Extensive ICSR management services, covering collection, triage, data entry, quality review, and medical review, all designed to facilitate the regulatory submission of ICSRs.
Meticulous gathering of individual case reports detailing adverse reactions, followed by a careful triage to determine the urgency and severity of each event.
Medical review, a pivotal step, involves the evaluation of cases by qualified healthcare professionals to determine causality, potential risks, and appropriate regulatory actions.
Regulatory submission of ICSRs, contributing to the overall safety profile of pharmaceutical products. Accurate and comprehensive ICSRs are submitted to regulatory authorities for evaluation and action.