Regulatory Dossier Preparation
with AI
Rule packs for required sections and source-linked extraction across modules, for reviewer checking.
eCTD and CTA submissions require precise cross-referencing.
Rule packs for required sections and source-linked extraction across modules, for reviewer checking.
Faster submissions. Fewer agency questions.
How DataStruct AI delivers Regulatory Dossier Preparation
Evidence-backed AI
Outputs cite the source paragraph. A verification pass flags claims it cannot match to the cited evidence.
Pharma domain pack
Pre-configured terminology, document types, and rule packs purpose-built for pharma.
Audit trail by default
Actions are logged and claims link to source. Assemble the evidence without the fire drill.
Access control and audit
Multi-tenant architecture with RBAC and audit logs. Tenant isolation is enforced in the application layer: each tenant-scoped route resolves your workspace membership and permissions before returning anything.
More Pharma use cases
Patent Landscape Analysis
Claim and priority-date extraction across the patent set, with source links for counsel.
Competitive Pipeline Intelligence
Extraction of pipeline data (compound, indication, phase, sponsor) from the documents you upload, each linked to source.
Scientific Literature Evidence Extraction
Upload the publications, define the fields, and extract them with source links; ask questions across the set with citations.
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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