Intelligent dossier construction, section by section, market by market.
QuriousRI’s Dossier Authoring module transforms the way regulatory dossiers are built. Upload your existing documents (study reports, analytical data, manufacturing records, clinical data) and the platform automatically classifies them to the correct CTD/eCTD sections, extracts relevant content, populates each section, and identifies what’s missing, insufficient, or non-compliant against that market’s requirements. The result is a structured, submission-ready dossier draft with a clear action list, built in a fraction of the time a manual authoring process takes.
Key Features of the QuriousRI Dossier Authoring Module
1. Document Upload & Intelligent Classification
- Upload individual files or entire folders, and the platform will auto-classify each document to its correct CTD section (Module 2, 3, 4, 5) with a confidence score.
- Supports all standard file formats (PDF, Word, Excel, XML, eCTD packages)
- Manual override is available where auto-classification needs correction.
- Handles both fresh dossiers and amendments to existing dossiers.
2. Section-Wise Content Extraction & Population
- AI extracts relevant data from uploaded documents and maps it to the corresponding fields in the CTD sections.
- Supports Module 3 (CMC: drug substance, drug product, appendices) and Module 5 (clinical: biopharmaceutics, BE/BA studies, clinical study reports)
- Section-level review allows you to accept, edit, or flag each extracted item.
3. Completeness & Compliance Alerts
- Flags missing sections, insufficient content, and format non-compliance against the target market’s CTD/eCTD requirements.
- Each alert states exactly what is missing, what the requirement is, and cites the relevant guideline or agency source.
- Displays the level of severity (critical gaps (will prevent acceptance) vs. minor gaps (may trigger queries)) which resolves in real time as documents are uploaded, and gaps are addressed.
4. Multi-Market Authoring
- Allows you to author dossiers for multiple markets simultaneously from a single set of documents.
- Market-specific requirements are applied automatically so that the same content is assessed against the target countries simultaneously.
- Highlights where additional country-specific documents or data packages are required (e.g., regional annexes, local labeling).
5. eCTD Format Handling
- Takes in existing eCTD submissions and applies format translation for markets which require different structures
- Validates eCTD structure, file naming conventions, and metadata against market-specific technical specifications
- Generates a compliant eCTD backbone where required
6. Collaborative & Gap-to-Action Workflow
- Different team members can own, review, and sign off on different modules simultaneously
- Comment threads, tracked changes, and version history per section
- Status tracking per section: not started / in progress / under review / complete
- Audit trail of all changes, reviews, and approvals with timestamps and user attribution
- Each identified gap comes with a recommended action: what document is needed, what data is required, what guideline specifies it
- Actions can be assigned to team members with due dates
- Progress is then tracked against the full gap list until the dossier is completed
7. AI Authoring Assistant
- Chat with any uploaded document to ask questions, request summaries, extract specific data points
- Draft section narratives based on extracted data (e.g., generate a manufacturing process description from uploaded batch records)
- Flags inconsistencies across documents within the same dossier (e.g., strength stated in one document doesn’t match another)
Key Benefits of the QuriousRI Dossier Authoring Module
- Reduced authoring time with auto-classification and content extraction.
- Built-in compliance from the start: Market-specific requirement checks run as you build and the gaps are caught during authoring.
- Single source for multiple markets: One set of documents can help generate multiple market-specific dossier outputs, avoiding the duplication of effort for building each.
- Team collaboration at a scale: The module’s collaborative workflow keeps everyone working in the same environment rather than across scattered documents and email chains.
- Traceable, Audit-Ready Output: Every content decision, gap flag, and section approval is logged, so the final dossier comes with a full authoring history.
- Reduced Agency Queries: Compliance alerts catch format issues and missing content before submission.
Competitive Advantages
- From upload to structured draft: QuriousRI reads your existing documents and populates the structure from them.
- Compliance check is built into authoring, not separately: Gap assessment and dossier construction happen in the same workflow.
- Market-specific, not generic CTD: The platform applies each target market’s specific requirements, not just the base ICH CTD structure, so a section that satisfies EU requirements but needs additional content for Brazil flags that difference automatically.
- Cross-document consistency checking: Identifies contradictions between uploaded documents (e.g., mismatched strengths, different manufacturer details across sections) before they cause queries or rejection.
- Feeds directly into Gap Assessment module: Dossier content built here is also fed into the Gap Assessment module for formal section-wise gap reporting.
Conclusion
QuriousRI’s Dossier Authoring module is designed to make CTD/eCTD preparation more structured and manageable by bringing document classification, content population, compliance review, and team collaboration into one workflow.
For regulatory teams working across CMC and clinical content, this can help reduce repetitive manual effort, improve visibility of gaps, and support more consistent dossier preparation across markets.
Explore QuriousRI to learn more about Artixio’s regulatory intelligence platform.
FAQs
What does the Dossier Authoring module actually do?
It takes your existing regulatory documents (analytical data, manufacturing records, clinical data, etc.) and builds a structured CTD/eCTD dossier from them. The platform reads and classifies each document to the correct section, extracts the relevant content, pre-populates each section, and flags anything that’s missing/doesn’t meet the target market’s requirements so you’re reviewing and refining a draft rather than building everything from scratch.
What modules and sections of the CTD does it cover?
The module currently covers Module 3 (CMC: drug substance, drug product, appendices, regional information) and Module 5 (clinical: biopharmaceutics and bioequivalence studies). Module 2 summaries (QOS, clinical overview, nonclinical overview) are in scope as an output generated from the content in Modules 3 and 5.
Do I need to have my documents organized in a specific format before uploading them?
No. You can upload documents in any order, individually or as a folder. The platform classifies each document to its correct CTD section automatically, with confidence scores shown for each classification. You review and confirm or manually override as needed.
Can multiple people work on the same dossier at the same time?
Yes. The module supports team workflows where different sections can be assigned to different team members working simultaneously. Each section has its own review status, comment thread, and sign-off record, with a full audit trail of who changed what and when.
