Typically, the creation of CMC dossiers is a manual process. The development of a medicinal product is long and data is acquired during a long period. Data resides in silos across the organization and partners like CDMOs / CROs (Contract Development and Manufacturing / Research Organizations). It is gathered in tedious processes from different data sources like Electronic Lab Notebooks (ELN), stability study reports, investigations, substance characterization, process development reports or reports from CDMOs and CROs. These processes are mainly manual thus time-consuming and error-prone.
Data centricity, digitalization and automation is the most viable solution to tackle the challenges for CMC content authoring. Three key areas will be improved by taking a “Structured Documents” approach - Data to Document, Authored Experience and Content Lifecycle Management.
Download this eBook to learn how BIOVIA Structured Documents can add measurable value to your organization by making this step towards data-centric dossier creation.