Regulatory Submissions
with AI
Automated cross-reference checking, citation validation, and compliance gap detection.
FDA and EMA submissions require precise cross-referencing across thousands of pages.
Automated cross-reference checking, citation validation, and compliance gap detection.
Fewer agency questions. Faster approval timelines.
How DataStruct AI delivers Regulatory Submissions
Evidence-backed AI
Every output cites the source paragraph. Verification pass catches fabricated claims.
Healthcare domain pack
Pre-configured terminology, document types, and rule packs purpose-built for healthcare.
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 Healthcare use cases
Systematic Reviews
AI screens thousands of papers, extracts study data, and synthesises evidence with PRISMA-compliant outputs.
Adverse Event Detection
NLP extraction of adverse events with severity classification and aggregation.
Medical Literature Monitoring
Custom alerts on PubMed, journals, and conference abstracts with AI-generated summaries.
Run Regulatory Submissions on DataStruct AI
Tell us what you're working with. We'll spin up a tailored workspace and walk your team through it.
Book a demo