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Accelerate regulatory submissions from source documents to submission-ready dossiers with AI-powered authoring, assembly, and validation. Reduce manual effort and errors while maintaining traceability, compliance and human oversight throughout the submission process, orchestrated by army of AI agents.
Watch how our AI agents orchestrate the complete submission lifecycle - from source document ingestion to a validated, multilingual dossier ready for FDA, EMA, or any of 60+ regulatory authorities.
Regulatory submissions are among the most expensive deliverables in pharma. The risks are routinely underestimated - until a submission fails a technical gateway check at 11:45pm on the filing deadline.
Experienced medical writer time consumed for every submission, across every market.
A single wrong-version inclusion can trigger a major objection from FDA or EMA reviewers.
Broken hyperlinks, wrong file formats, missing sections — costly resubmissions at the worst moment.
Coordinating Modules 1–5 across jurisdictions is compliance complexity spreadsheets cannot solve.
Dedicated agents continuously collaborate to author, collate, classify, cross-reference, validate, translate, and assemble with complete traceability and regulatory oversight.
Wizr eCTD Studio is an end-to-end authoring and assembly engine - not a document management system with an AI marketing layer.
Drafts eCTD narrative sections directly from your CSRs, preclinical summaries, and CMC data. Consistent structure and quality - regardless of which writer is assigned.
↑ Up to 70% fasterReal-time compliance checks during assembly. Region-specific Module 1 requirements handled automatically for 60+ country submissions.
✓ eCTD 4.0 compliantVerifies every table, figure, and citation across all five modules. Nothing reaches the reviewer out of order, duplicated, or with a broken reference.
✓ All 5 modules verifiedCatches every gateway error before a file is uploaded — broken hyperlinks, missing files, incorrect formats, and eCTD structural violations eliminated.
✓ Zero gateway failuresAutomated translation and localisation for multi-market submissions. Regulatory terminology preserved with jurisdiction-specific adaptations.
✓ 60+ marketsRegulatory leads receive a fully validated dossier with AI review summaries, flagged risks, and audit trails. Humans approve all critical decisions.
✓ Full audit trailFor a product with even modest commercial projections, a 16–20 week delay from a preventable technical error represents millions in lost revenue. Wizr's pre-submission validation suite eliminates that category of risk entirely.
Wizr delivers production-ready AI systems for eCTD authoring, assembly, and validation. Let's build yours - faster, with zero gateway surprises.
