The regulatory operating system for modern biotech.
Your IND isn't a collection of documents. It's a system. Build it like one.
Your IND isn't a collection of documents. It's a system. Build it like one.
The regulatory operating system for modern biotech.
Your IND isn't a collection of documents. It's a system. Build it like one.
AI generates. Experts validate. Everything is traced.
Submission Generation
Workflow Orchestration
Process-level Audit Trail
Expert Validation
Generate regulatory documents using your knowledge base
Build your submission dossier with full source attribution.
Human-like ai chat generative ai feature
Deliver fast, natural conversations powered by AI without increasing your support team.
Smart system integration
Easily connect channels, tools, and workflows to power unified support across your ecosystem.
Chats that feel human but powered by AI
Deliver instant, intelligent, and always-on support — without scaling your team.
Submission Generation
Workflow Orchestration
Process-level Audit Trail
Expert Validation
Generate regulatory documents using your knowledge base
Build your submission dossier with full source attribution.
Human-like ai chat generative ai feature
Deliver fast, natural conversations powered by AI without increasing your support team.
Smart system integration
Easily connect channels, tools, and workflows to power unified support across your ecosystem.
Chats that feel human but powered by AI
Deliver instant, intelligent, and always-on support — without scaling your team.
Submission Generation
Workflow Orchestration
Process-level Audit Trail
Expert Validation
Generate regulatory documents using your knowledge base
Build your submission dossier with full source attribution.
Human-like ai chat generative ai feature
Deliver fast, natural conversations powered by AI without increasing your support team.
Smart system integration
Easily connect channels, tools, and workflows to power unified support across your ecosystem.
Chats that feel human but powered by AI
Deliver instant, intelligent, and always-on support — without scaling your team.
AI can generate your IND. But who's accountable for it?
Build submission packages using your knowledge base
Import FAQs, support docs, chat logs, or help center content. Our AI instantly learns everything.
Build submission packages using your knowledge base
Import FAQs, support docs, chat logs, or help center content. Our AI instantly learns everything.
Build submission packages using your knowledge base
Import FAQs, support docs, chat logs, or help center content. Our AI instantly learns everything.
Built-in accountability with regulatory experts
Every output validated by domain experts.
Built-in accountability with regulatory experts
Every output validated by domain experts.
Built-in accountability with regulatory experts
Every output validated by domain experts.
Full audit trail for every document and decision
100% document and decision provenance
Full audit trail for every document and decision
100% document and decision provenance
Full audit trail for every document and decision
100% document and decision provenance
Not a tool. Not a platform. We're the infrastructure.
Built-In Audit Trails
Every decision traced, recorded, and defensible.
Expert-Validated Outputs
Domain specialists review before anything ships.
21 CFR Part 11 Ready
Compliance by designed from day one.
Workflow Orchestration
Cross-functional review and sign-off gates.
Regulatory Guidance
Context-aware answers with source attribution.
Decision Provenance
Know what was decided, when, and why.
IND-to-Submission
From protocol through eCTD-ready packages.
Connected Documents
One change propagates across all linked docs.
Your question answered
Need answers? We’ve got you covered.
Below are some of the most common questions people ask us. If you can’t find what you’re looking for, feel free to reach out!
Is ARI designed for GxP-regulated environments?
Yes. ARI is architected from the ground up with regulated work in mind — including 21 CFR Part 11 design principles, process-level audit trails, and formal sign-off workflows. We don't treat compliance as an afterthought or a feature request. Traceability, accountability, and auditability are built into the core of the system.
Who is accountable when AI generates content for a regulatory submission?
How is this different from other AI tools that draft regulatory documents?
How do the domain experts fit into the workflow?
Your question answered
Need answers? We’ve got you covered.
Below are some of the most common questions people ask us. If you can’t find what you’re looking for, feel free to reach out!
Is ARI designed for GxP-regulated environments?
Yes. ARI is architected from the ground up with regulated work in mind — including 21 CFR Part 11 design principles, process-level audit trails, and formal sign-off workflows. We don't treat compliance as an afterthought or a feature request. Traceability, accountability, and auditability are built into the core of the system.
Who is accountable when AI generates content for a regulatory submission?
How is this different from other AI tools that draft regulatory documents?
How do the domain experts fit into the workflow?
Your question answered
Need answers? We’ve got you covered.
Below are some of the most common questions people ask us. If you can’t find what you’re looking for, feel free to reach out!
Is ARI designed for GxP-regulated environments?
Yes. ARI is architected from the ground up with regulated work in mind — including 21 CFR Part 11 design principles, process-level audit trails, and formal sign-off workflows. We don't treat compliance as an afterthought or a feature request. Traceability, accountability, and auditability are built into the core of the system.
Who is accountable when AI generates content for a regulatory submission?
How is this different from other AI tools that draft regulatory documents?
How do the domain experts fit into the workflow?
Regulatory operations shouldn't run on documents and spreadsheets.
Go from data to filing, with complete traceability and accountability.
Regulatory operations shouldn't run on documents and spreadsheets.
Go from data to filing, with complete traceability and accountability.
Regulatory operations shouldn't run on documents and spreadsheets.
Go from data to filing, with complete traceability and accountability.