Orchestrated workflows

Orchestrated workflows

Full provenance

Full provenance

Part 11, GxP-ready

Part 11, GxP-ready

Expert validation

Expert validation

An Operating System
for Submissions

With built-in accountability

See how ARI works

Packed with Powerful,
Regulatory-Grade Features

01

Regulatory work is a team sport. Your tools should know that.

ARI orchestrates cross-functional review, approval, and sign-off workflows, so nothing moves forward without the right people weighing in.

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01

Regulatory work is a team sport. Your tools should know that.

ARI orchestrates cross-functional review, approval, and sign-off workflows, so nothing moves forward without the right people weighing in.

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02

When the FDA asks "why was this decision made?", your answer is already in the system.

ARI captures the full chain of evidence behind every document, every decision, and every change, from source data through final sign-off.

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02

When the FDA asks "why was this decision made?", your answer is already in the system.

ARI captures the full chain of evidence behind every document, every decision, and every change, from source data through final sign-off.

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Regulatory intelligence grounded in real documents

ARI answers regulatory questions using your organization's documents and official agency guidance, with source links, not guesswork.

● Source-linked regulatory Q&A

● Agency guidance + internal docs, unified

● Context-aware, not keyword-matched

● Always current, always citable

Learn more

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Audit-native
System of Record

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.

Get Started Today

Human-like ai chat generative ai feature

Deliver fast, natural conversations powered by AI without increasing your support team.

Get Started Today

Smart system integration

Easily connect channels, tools, and workflows to power unified support across your ecosystem.

Get Started Today

Chats that feel human but powered by AI

Deliver instant, intelligent, and always-on support — without scaling your team.

Get Started Today

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.

Get Started Today

Human-like ai chat generative ai feature

Deliver fast, natural conversations powered by AI without increasing your support team.

Get Started Today

Smart system integration

Easily connect channels, tools, and workflows to power unified support across your ecosystem.

Get Started Today

Chats that feel human but powered by AI

Deliver instant, intelligent, and always-on support — without scaling your team.

Get Started Today

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.

Get Started Today

Human-like ai chat generative ai feature

Deliver fast, natural conversations powered by AI without increasing your support team.

Get Started Today

Smart system integration

Easily connect channels, tools, and workflows to power unified support across your ecosystem.

Get Started Today

Chats that feel human but powered by AI

Deliver instant, intelligent, and always-on support — without scaling your team.

Get Started Today

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.

Learn More

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!

Contact us

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!

Contact us

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!

Contact us

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.

Get Started Today

Regulatory operations shouldn't run on documents and spreadsheets.

Go from data to filing, with complete traceability and accountability.

Get Started Today

Regulatory operations shouldn't run on documents and spreadsheets.

Go from data to filing, with complete traceability and accountability.

Get Started Today