Keep Module 3 and the QOS aligned as your evidence evolves.
One source change. Multiple sections to review.
A revised specification, analytical method, or stability conclusion can affect multiple sections of your CMC dossier. How do you know what needs to change, and why?
Download this white paper to explore a connected, AI-assisted approach to keeping Module 3 and the Module 2.3 Quality Overall Summary (QOS) aligned, from source evidence to draft content and controlled updates. Scientific judgment and approval stay with your experts.
What you'll take away
A six-step workflow for change review. Follow a source change through impact assessment, proposed revisions, expert review, and recorded decisions.
An evidence-first approach to drafting. Explore how source-linked drafts can connect CMC content to controlled evidence and make missing inputs visible.
QC that respects scientific context. Distinguish potential inconsistencies from justified differences, including release versus shelf-life limits and process set points versus operating ranges.
Five dimensions for evaluating AI-generated content. Assess accuracy, completeness, consistency, factuality, and traceability, with practical questions to ask suppliers.
A clearer view of the draft ICH M4Q(R2) structure. Understand why R1-to-R2 mapping requires scientific gap assessment, not just new headings.
For CMC, Regulatory-CMC, Quality, and R&D Digital & AI leaders evaluating AI-assisted authoring and dossier change management.
See how AuroraPrime connects evidence, drafting, and review in an expert-led CMC workflow.
Get the workflow and evaluation framework. Download your free copy.
