Navitas Life Sciences

Managing a complex PV engagement by leveraging safetyREADY to deliver process optimization

Our client a mid-sized global pharmaceutical company headquartered in South Korea is developing new biologics and innovative drugs. They were seeking a partner to support them in activities relating to ICSR case processing, regulatory submissions, and translations.

Our client is regularly conducting Observational/Post-Marketing Surveillance (PMS) Studies. As a result, Adverse Events (AEs) from these studies are returned as bulk cases in batches of ~500 to 2500 as line listings from the clinical database. In addition, there is a requirement for spontaneous cases to be processed and submitted. Both the bulk and spontaneous cases necessitate the translation of source documents from Korean to English, all within a short timeframe and while adhering to committed and demanding turnaround times.

Please complete the form to download the Case Study and learn how, in just 7 days, we submitted ~2500 cases to the Ministry of Food and Drug Safety (MFDS) meeting the Regulatory timelines with a 100% quality record.

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