From source documents to compliant submission dossier — faster, with fewer errors, and zero gateway surprises. Powered by an orchestrated army of specialised 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.
