www.rednucleus.com contact us at info@rednucleus.com Case Study R&D COMPLIANCE WITH TIME-SENSITIVE SUBMISSIONS Client Challenge The client, a large global pharmaceutical company, was anticipating an audit by the FDA for several of its time-sensitive submissions. This client did not have visibility in the end- to-end process, was unable to track or report on the status of these submissions, and was at risk of receiving a warning letter for noncompliance. The client required an assessment and optimization of the processes and supporting procedural documentation to ensure compliance with regulated submission timelines and a mechanism for tracking and reporting against those timelines. Some of the identified processes were cross-functional in nature and spanned multiple systems. Alignin

Join for free to read