Platform overview

The AI operating system for regulatory affairs teams

RegASK triages signals, turns information into insight, and coordinates the actions that follow. Streamline workflows, enable team collaboration, and free your team to focus on the strategic work.

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How RegASK works

From signal to action,
in one operating system

Know

Surface the signals that matter.

Act

Move regulatory work forward.

Connect

Built to fit your enterprise architecture.

Trust

Enterprise-grade security. Embedded AI governance.

know

Surface the signals that matter

Continuous regulatory monitoring across 160+ markets, filtered, prioritized, and ready to act on.

Real-time signals

Your regulatory radar

With Alerts, detect and prioritize regulatory change in real time, tagged by impact across products and markets.

Trends & foresight

Foresight, not just feeds

With Insights, spot trends and anticipate risk early, turning regulatory signals into clear, leadership-ready insights.

AI-assisted assessments

Impact and risk, on demand

Agentic AI agents translate, summarize, triage, and structure regulatory content at scale, so your team assesses what each change means for products, markets, and submissions, fast.

Personalized workspace

Your Vault

Your personalized regulatory workspace. Keep the source documents, internal SOPs, and external guidances your team works from every day in one place.

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act

Move regulatory work forward

Workflows, AI agents, and on-the-ground experts — coordinated in one operating system.

Conversational AI

RegASK
Assistant

Agentic AI agents translate, summarize, triage, and structure regulatory content at scale, so your team assesses what each change means for products, markets, and submissions, fast.

Workflow orchestration

Your regulatory command center

Using ActionHub, track changes, manage workflows, and trigger actions from a single-view dashboard.

Human expertise

Deep-dive expertise, on demand

Through the RegASK Experts Community of 1,800+ regulatory practitioners across 160+ markets, get local deep dives, on-the-ground support, due diligence, and dossier-ready submissions when the work calls for human judgment.

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connect

Built to fit your enterprise architecture

RegASK connects through APIs, agent-to-agent coordination, and MCP — so regulatory intelligence flows where your teams already work.

Esko

AI-assisted label compliance

Operationalize regulatory intelligence and bring artwork closer to compliance review.

Veeva Vault RIM

Submissions, connected to intelligence

RegASK connects regulatory intelligence with submission management.

Microsoft Azure Marketplace

Procure on
Azure

Streamlined procurement, deployment, and billing through your existing Azure commitments.

trust

Enterprise-grade security, embedded AI governance

RegASK meets the highest industry standards for security and compliance. We include all the default controls enterprise teams expect: SAML SSO, audit logs, IP allow-listing, data lifecycle management, and more.

ISO 27701

ISO 42001

ISO 27001

ISO 27018

SOC 2 Type II

GDPR

ECOVADIS

ISO 27701

ISO 42001

ISO 27001

ISO 27018

SOC 2 Type II

GDPR

ECOVADIS

RegASK is the first company in its category to achieve ISO/IEC 42001 certification for AI Management Systems, and holds a unique set of six independent certifications across AI governance, security, privacy, and sustainability.

More about security

Value from Day 1

Outcomes our customers see

Regulatory research time cut by up to 80%.
Audit-and inspection-ready.
One source of regulatory truth across teams.

800+
queries run per day

6M+
regulatory data points

18K
regulatory actions executed per month

138K+
platform engagement events per month

160+
territories covered

“We rely on the RegASK platform for its responsiveness, speed, and flexibility.”

Miro Smriga
Global Director of Regulatory and Scientific Affairs
Ajinomoto

BUILT WITH YOUR TEAM IN MIND

One System Behind Confident Execution

Command Center

Control regulatory operations from one place

Track change, manage workflows, and trigger actions from a single view

Monitoring

See regulatory change as it happens

Near real-time tracking across 160+ markets, prioritized by product, market, and business relevance

Intelligence

Turn regulatory signals into structured insight

AI agents analyze, summarize, and classify content, accelerating the path from signal to decision

Regulatory Assistant

Ask regulatory questions and get cited answers instantly

Interact in natural language and receive contextual, source-grounded responses

Expert Validation

Validate critical insights with human expertise

1,800 Regulatory experts-in-the-loop add local context, review, and confidence where it matters most

Workflows

Move from insight to coordinated action

Assess impact, assign tasks, and manage execution through structured workflows and timelines

Integrations

Connect regulatory intelligence to your systems

Deliver structured outputs into Veeva Vault RIM, QMS, labeling, and product lifecycle workflows

Content Curation

Cut through noise and focus on what matters

Curated, prioritized content tailored to your products, markets, and risk areas

Risk Management

Identify and manage regulatory risk early

Detect risks before they impact compliance, timelines, or product launches

Impact Assessment

Understand how regulatory change affects your business

Assess impact across products, markets, and functions in a single view

Insights

Turn regulatory data into decision-ready insight

Spot trends, surface risks, and inform leadership with clarity

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Enterprise foundation

Built for Controlled, Scalable Regulatory Operations

We transform regulatory intelligence into a connected, auditable enterprise system.

Read about April 2026 release

Governance

Ensure every regulatory action is controlled, approved, and accountable.

Enabled through structured workflows and role-based controls.

Traceability

Track every signal, decision, and change with a complete audit trail.

Maintained across systems and workflows.

Connectivity

Connect near-real-time regulatory signals with enterprise systems.

Delivered via API, agent-to-agent coordination, and MCP.

See it in action

See the regulatory operating system in action

See how RegASK frees your team to focus on the work that matters most.

Request a demo