NAVIGATING THE COMPLEXITIES OF DOCUMENTS IN CMC DOSSIERS
A study published in the Journal of Pharmaceutical Sciences offers a compelling outlook on the future of CMC regulatory submissions. Researchers predict a shift from traditional documentation to structured content and data management (SCDM) for dossiers. This strategic transition is anticipated to significantly streamline the process of CMC regulatory submissions. In this white paper, we will explore the challenges organizations encounter with traditional documents, and how adopting SCDM for CMC authoring can result in substantial benefits across various business operations.