RegXP
Launch with precision. Scale with certainty.
Faster Drafts. Smarter Reviews. Confident Submissions.
Accelerate Drafting Without Losing Control
Accelerate Drafting Without Losing Control
Regulatory document delays are rarely a science problem. They are a process problem driven by manual data pulls, fragmented reviews, and endless reconciliation cycles. RegXP – Content Generator eliminates these bottlenecks. From CSRs and DSURs to ICFs, PLPS, and eCRFs, it connects your validated data sources to governed templates and structured workflows, so teams draft faster, review smarter, and submit with confidence.
Platform Performance
Real Results. Regulatory Ready.
Delays in regulated document authoring are rarely caused by lack of expertise. They are driven by manual consolidation, reconciliation cycles, and fragmented review workflows. Our platform reduces these bottlenecks while maintaining governance across every document type and every regulatory domain.
Automated Document
AI agents extract, structure, and draft regulatory content across all supported document types, drawing from validated clinical and safety data sources.
Regulatory Compliant
Every generated document aligns to ICH E3, ICH E2F, and global regulatory standards, compliance embedded into the generation pipeline, not added after the fact.
Faster Submission
Accelerates generation and review of regulated documents without compromising quality, traceability, or governance.
Document Coverage
One Intelligent Platform . No Limits.
One governed platform. Seven document types. A roadmap built to scale with your regulatory landscape.
Current Document Coverage
CSR
eCRF
PLPS
DSUR
ICF
PSUR
Patient Narratives
Built to Grow With You
This is just the beginning. As regulatory demands evolve, so does RegXP – actively expanding to cover every document your teams will ever need.
End-to-End Workflow
Five Steps from Data to Done
A structured, governance-driven framework that transforms regulated document creation from fragmented drafting into a controlled, traceable, and accelerated lifecycle.
Configure Documents
Define the study or product context, select source documents, and choose the regulatory template aligned to your document type and jurisdiction.
Generate
Six specialised AI agents extract, process, and draft the document section by section with inline citations automatically attached from your source data.
Quality and Preview
Review section-level quality scores, follow citation links to source evidence, and identify exactly which sections need attention before human review begins.
Review
Collaboratively refine content, regenerate individual sections with specific instructions, assign reviewers, and route for formal approval.
Download
Export a submission-ready, template-aligned Word document with a generated table of contents, fully assembled and ready for regulatory submission.
End-to-End Workflow
Precision-Built for Every Stage
Enterprise-grade capabilities designed to combine AI-driven efficiency with regulatory control, ensuring speed, accuracy, and compliance across every regulated document workflow.
AI Powered Generation
Six specialised AI agents automatically extract, structure, and draft regulated content across CSR, ICF, PLPS, DSUR, and eCRF workflows from validated clinical and safety data sources.
Structured Review Workflow
Section-level collaboration, structured approval routing, and controlled stakeholder engagement across every document type and regulatory domain.
Faster Verification via Inline Citations
Every generated claim is automatically traced back to its source document and page reference, enabling faster validation and significantly reduced rework.
Version Control and Governance
Full audit trail, version history, role-based access control, and complete document lifecycle visibility from generation through to approved output.
Seamless Data Source Integration
Native connectors to Veeva Vault, Oracle Argus, Google Drive, AWS S3, EDC systems, and more, bringing all your clinical and safety data into one governed generation environment.
See RegXP Automation in Action
Experience structured AI assistance built for regulated RegXP workflows.