Navitas Life Sciences

Successfully leveraging automation for expedited end-to-end ICSR processing and submissions

Our client is a global pharmaceutical company, focusing on the development and manufacturing of IP-led niche finished dosage formulations that are sold in 100+ countries. With the US FDA having requested the withdrawal of Ranitidine drugs from the market, and with litigation progressing, our client was seeking a partner to help them to process some 17,000+ complex litigation Individual Case Safety Reports (ICSRs). With a tight deadline of 120 days, our client needed to ensure the regulatory submissions were received by the US FDA as per product approval and regulatory requirements.

Please complete the form to download the Case Study and learn how we worked with our client to ensure successful data review and mapping to structured fields, migration of data, processing, and the necessary submission of ICSRs to meet regulatory requirements.

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