What Is An ICSR?

An ICSR is the individual case safety report that captures information needed to support the reporting of the drug following the adverse event. We report on valid cases that have the minimum reporting criteria in compliance with the specified timelines.

Your company needs to be compliant with the regulation changes for ICSR reporting. Without accurate and compliant ICSRs, you could face costly penalties for not complying with the EU drug safety laws.

When your company sets up contractual arrangements with Almond Pharma, a detailed Safety Data Exchange Agreement (SDEA) will outline the processes for the exchange of safety information, including timelines and regulatory reporting responsibilities avoiding duplicate reporting to the necessary authorities.

Why Choose Almond Pharma For Your ICSRS?

Our drug safety consultant team make sure your submissions to the appropriate authorities are seamless and compliant in order to help you avoid heavy and costly penalties accumulated through non-compliance.

Almond Pharma uses a validated and secure safety database with reliable backup and disaster recovery programmes in place. We offer a cost-effective solution for managing your safety data as well as taking care of your company’s future needs for processing ICSRs.

Our experienced pharmacovigilance physicians are experts in reviewing MedDRA coding and medical assessments of all cases with the thorough quality control service we offer for each report. For electronic reporting we have a specialised submissions team who are trained users of EudraVigilance. We understand the need for time restraint compliance. If need be, we can tailor our established standard practices to your specific requirements.

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