Start from approved sources
Bring Module 3 content, established specifications, process descriptions, and sponsor-approved materials into a controlled authoring workflow.
NARRATIVA · REGULATORY
Quality Overall Summary Automation with AI Agents
Bring pharmaceutical quality information into a clear, structured CTD Module 2.3 draft—with source-aware authoring, cross-document checks, and quality.
AI AGENTS TRUSTED BY LIFE SCIENCES ORGANIZATIONS
QUALITY OVERALL SUMMARY · COORDINATED AI AGENTS
Connect. Structure.
Review with confidence.
Purpose-built agents help regulatory and CMC teams organize approved quality information, prepare a structured summary, and focus expert review on consistency, traceability, and completeness.
Map content to CTD sections
Organize relevant information into the applicable Module 2.3 structure, including drug substance, drug product, appendices, and regional sections.
Draft with source context
Prepare concise summaries from selected source material while retaining links that help reviewers verify technical statements and supporting data.
Check cross-document consistency
Surface potential differences between the summary and detailed quality sections, specifications, process descriptions, or supporting tables for assessment.
Support quality review
Flag terminology, figures, tables, and references that may need attention, with qualified CMC and regulatory reviewers deciding what to change.
Keep decisions with experts
Manage review comments and document versions while qualified subject-matter experts retain responsibility for scientific accuracy and final approval.
MEDICAL AUTHORING COMPANION · QUALITY MODULE
Turn detailed quality evidence into a coherent summary.
The Quality Overall Summary (QOS) is CTD Module 2.3, a high-level summary of the quality information presented in Module 3 of a Common Technical Document. Its sections typically cover drug substance, drug product, appendices, and applicable regional information, following the relevant CTD structure and requirements.
Medical Authoring Companion helps teams organize approved quality content, prepare source-linked drafts, and check consistency across the summary and detailed quality sections. CMC and regulatory experts remain responsible for technical interpretation, accuracy, and approval of the final document.
QUALITY OVERALL SUMMARY · FAQ
Quality summaries, with evidence in view.
Learn how AI-assisted workflows can support CTD Module 2.3 preparation and review.
What is a Quality Overall Summary?
The Quality Overall Summary (QOS) is CTD Module 2.3. It summarizes quality information for a medicinal product, with detailed supporting information presented in Module 3, according to the applicable CTD structure and regional requirements.
What information is covered in Module 2.3?
Depending on the product and applicable requirements, the QOS covers drug substance, drug product, appendices, and regional information. It summarizes topics such as manufacture, characterization, controls, specifications, and stability, with detailed evidence in Module 3.
How can AI agents support QOS preparation?
Agents can help organize approved source content, draft structured summaries, retain source references, and flag potential gaps or inconsistencies. CMC and regulatory experts verify the content and determine the final wording.
How can teams check the QOS against Module 3?
Configured source-aware checks can compare summaries, terminology, figures, tables, specifications, and process descriptions across related documents, surfacing potential discrepancies for qualified review.
Does an AI-generated QOS replace CMC or regulatory review?
No. AI supports drafting and review activities; it does not replace qualified subject-matter judgment, sponsor procedures, or the required review and approval of the regulatory submission.
Can the workflow follow different CTD or regional requirements?
Teams can configure authoring around applicable templates, product context, and regional requirements. Regulatory experts confirm the required structure and content for each submission.