ICSR (Individual Case Safety Report) Management

At Dr. Mwiko Health Solutions Ltd, we provide end-to-end ICSR management solutions designed to ensure compliance, efficiency, and scientific integrity across all stages of case handling. Our experienced pharmacovigilance professionals manage the entire process from case intake, triage, data entry, and quality review to medical evaluation and regulatory submission ensuring accurate and timely reporting in accordance with global and regional requirements.

We support safety case management across diverse product categories, including pharmaceuticals, biologics, biosimilars, radiopharmaceuticals, nutraceuticals, cosmetics (cosmetovigilance), and medical devices (materiovigilance).

Our approach combines global standards with local expertise, allowing clients to maintain compliance while optimizing operational efficiency throughout the product lifecycle.

Comprehensive ICSR Management Solutions

• End-to-end case processing: Collection, triage, data entry, medical review, quality control, and regulatory submission
• Case reconciliation: Conducted periodically as per Pharmacovigilance Agreements (PVAs) and Safety Management Plans, covering affiliates, partners, medical information, product complaints, and clinical trial teams

• Safety database management: Support for case processing and migration activities across multiple validated systems, including Argus, ARISg, Veeva, Sapheus, and BPI Pheda, as well as custom-built solutions

Why Partner with Us

At Dr. Mwiko Health Solutions, we understand that efficient safety case management is about building trust and protecting patients. We help you reduce workload, increase accuracy, and maintain full regulatory alignment while keeping costs under control.

We combine deep pharmacovigilance expertise and regional insight to help you achieve operational excellence and safety oversight.