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ACD/Labs Blog

This presentation provides an overview of the current state of research into N-nitrosamine impurities; what have we learned from systematic risk assessment, and what comes next.

How Chemical Manufacturing and Control (CMC) Software Helped a Major Pharmaceutical Company Improve Process Development and Regulatory Submissions Background: in 2019, a process development team at a top biopharmaceutical company. They felt data management was getting in the way of research and that too much time was spent preparing regulatory submissions. Challenge: the team wanted...