Regulatory Dossier Preparation
with AI
Automated cross-reference checking and consistency validation across modules.
eCTD and CTA submissions require precise cross-referencing.
Automated cross-reference checking and consistency validation across modules.
Faster submissions. Fewer agency questions.
How DataStruct AI delivers Regulatory Dossier Preparation
Evidence-backed AI
Every output cites the source paragraph. Verification pass catches fabricated claims.
Pharma domain pack
Pre-configured terminology, document types, and rule packs purpose-built for pharma.
Audit trail by default
Every action logged. Every claim traceable. Pass audits without the fire drill.
Built to scale
Multi-tenant architecture with SSO, RBAC, audit logs, and SOC 2 (in progress). Scales to thousands of users without losing tenant isolation.
More Pharma use cases
Patent Landscape Analysis
Automated claim extraction, prior art mapping, and white-space identification.
Competitive Pipeline Intelligence
Continuous extraction of pipeline data with alerts on competitor moves.
Scientific Literature Surveillance
Daily AI-summarised digests with custom keyword and concept alerts.
Run Regulatory Dossier Preparation on DataStruct AI
Tell us what you're working with. We'll spin up a tailored workspace and walk your team through it.
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