Human-AI Orchestration for REGULATORY AFFAIRS

Spend your expertise on judgment, not assembly.

Spend your expertise on judgment, not assembly.

Schedule Demo

Human-AI Orchestration for REGULATORY AFFAIRS

Spend your expertise on judgment, not assembly.

Schedule Demo

Human-AI Orchestration for REGULATORY AFFAIRS

Spend your expertise on judgment, not assembly.

Schedule Demo

Human-AI Orchestration for REGULATORY AFFAIRS

Spend your expertise on judgment, not assembly.

Schedule Demo

The shift

Start from the work. Shift it to agents.

Start from the work. Shift it to agents.

Start from the work. Shift it to agents.

Asteri begins with the regulatory work your specialists do today — the real dossiers, assessments, and approval paths — then shifts compilation to governed agents one artefact at a time. Judgment stays with the reviewer.

Asteri begins with the regulatory work your specialists do today — the real dossiers, assessments, and approval paths — then shifts compilation to governed agents one artefact at a time. Judgment stays with the reviewer.

Human today

Human today

Governed agent

Governed agent

Dossier compilation

Dossier compilation

Agent-run

Agent-run

Requirement tracking

Requirement tracking

Agent-run

Agent-run

Change assessment

Change assessment

Agent-drafted

Agent-drafted

Submission approval

Submission approval

Human decides

Human decides

The foundation underneath

Work Intelligence · Simulation Engine · Governed AI Agents

Work Intelligence · Simulation Engine · Governed AI Agents

Regulatory expertise is spent on compilation, not judgment.

Regulatory expertise is spent on compilation, not judgment.

Regulatory expertise is spent on compilation, not judgment.

Where AI adds the most value — with humans in the loop at every decision.

Where AI adds the most value — with humans in the loop at every decision.

Where AI adds the most value — with humans in the loop at every decision.

01

Manual & repetitive

Specialists spend hours compiling dossiers, checklists, and assessments from files scattered across 20+ systems — time better spent on judgment and strategy.

Specialists spend hours compiling dossiers, checklists, and assessments from files scattered across 20+ systems — time better spent on judgment and strategy.

02

Hard to scale

As filing volume grows, the manual effort compounds — stretching scarce expertise and making the work harder to track and audit.

As filing volume grows, the manual effort compounds — stretching scarce expertise and making the work harder to track and audit.

03

Delays product launches

Every week lost in compilation pushes back approvals and market entry — delaying the moment a product reaches patients.

Every week lost in compilation pushes back approvals and market entry — delaying the moment a product reaches patients.

How it works

Three modules. One governed workforce.

Three modules. One governed workforce.

Three modules. One governed workforce.

Each module builds on the last. Together they make Human-AI Orchestration for regulatory affairs possible — the platform sees the work, tests the plan, then runs it.

Each module builds on the last. Together they make Human-AI Orchestration for regulatory affairs possible — the platform sees the work, tests the plan, then runs it.

Each module builds on the last. Together they make Human-AI Orchestration for regulatory affairs possible — the platform sees the work, tests the plan, then runs it.

01 · See the work

Work Intelligence

The platform automatically builds a live, task-level work graph of your filing operations — surfacing where compilation effort, duplication, and AI-readiness actually are.

The platform automatically builds a live, task-level work graph of your filing operations — surfacing where compilation effort, duplication, and AI-readiness actually are.

02 · Test the plan

Simulation Engine

Every agent is simulated against the real work graph before go-live — modeling outcomes, surfacing compliance risk, and generating the audit trail sign-off requires.

Every agent is simulated against the real work graph before go-live — modeling outcomes, surfacing compliance risk, and generating the audit trail sign-off requires.

03 · Run it

AI Agents

Governed agents — Regulatory Intelligence, Submissions, Document Comparison — grounded in work reality and validated through simulation, purpose-built for regulatory affairs.

Governed agents — Regulatory Intelligence, Submissions, Document Comparison — grounded in work reality and validated through simulation, purpose-built for regulatory affairs.

The result

Human-AI Orchestration

Humans and governed agents coordinated as one workforce across every filing — the right reviewer in the loop at each approval, every action auditable.

Humans and governed agents coordinated as one workforce across every filing — the right reviewer in the loop at each approval, every action auditable.

AI at every stage of regulatory work.

AI at every stage of regulatory work.

AI at every stage of regulatory work.

Predict change

Anticipate regulatory shifts across 120+ markets before they land — and flag the products they touch.

Draft continuously

Submissions and forms assembled the moment data is ready — humans review, the agent keeps writing.

Stay compliant, live

Every product current in every market — renewals, variations, and impact assessments handled proactively.

Own the judgment

Regulatory affairs decides and approves — freed from assembly to focus on strategy and risk.

The agent portfolio

Governed agents across regulated operations.

Regulatory Intelligence, Submissions, Document Comparison, and more — each validated before deployment and orchestrated alongside your teams.

Explore the Asteri AI agent portfolio

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