RegASK

RegASK is the AI-native regulatory operating system for global enterprises in highly regulated industries, including life sciences and consumer products.

Powered by agentic AI and a global community of 1,800+ regulatory experts across 160+ markets, RegASK helps organizations detect and curate regulatory change, assess impact, and orchestrate compliance workflows at scale.

RegGenius, the platform’s conversational interface, enables teams to interact with this intelligence in natural language, asking complex regulatory questions and receiving fast, source-grounded answers with full citations.

THE CHALLENGE WE SOLVE

Regulatory change is constant, fragmented, and difficult to act on across global markets. Teams rely on manual monitoring, fragmented information, disconnected workflows, and manual internal processes to identify and understand what changed, assess the impact, and act on it.

This leads to compliance gaps, delayed product launches, audit exposure, and operational inefficiencies.

WHAT REGASK DELIVERS

• Near Real-time Regulatory Monitoring: Continuous tracking across 160+ markets, filtered and prioritized by product, market, and business relevance

• Agentic AI for Regulatory Intelligence: AI Agents translate, summarize, triage, analyze and structure regulatory content at scale, enabling faster decision and action

• RegGenius, an AI Regulatory Assistant: Ask your regulatory questions and receive live, contextual answers with full source citations

• Expert-in-the-loop: A global community of regulatory experts supports critical insights with human review with local market context

• Impact & Risk Assessment and Workflow Orchestration: Assess regulatory impact across products and markets, and coordinate next steps through structured workflows and timelines

• Action Hub: Automate your workflow, track change and assign tasks, all from a single view

• Ecosystem Integration: Structured regulatory intelligence that can integrate into downstream systems (Veeva Vault RIM, QMS, product registration workflows, enterprise data lakes), API and A2A

• Global Coverage with Local Depth: From FDA and EMA to APAC, LATAM, MEA, and emerging markets, with local-language source handling and jurisdiction-specific expertise.

BUSINESS IMPACT

• Cut regulatory research time by up to 80%. Replace manual monitoring and document review with agentic AI that surfaces only what is relevant.

• Stay audit- and inspection-ready. De-risk global expansion. Enter and maintain compliance in new markets faster with a single, consistent intelligence layer.

• Empower every team. Regulatory affairs, quality, product, and R&D teams work from the same single source of regulatory truth.

ENTERPRISE-READY BY DESIGN

RegASK moves organizations from AI experimentation to scalable, enterprise-wide regulatory execution.

Governance, traceability, and connectivity are embedded into every workflow, ensuring decisions are controlled, auditable, and system connected.

• End-to-end traceability and audit-ready outputs

• Role-based governance and structured approvals

• Connectivity to enterprise systems and workflows

• Human-in-the-loop validation

• AI governance aligned with ISO/IEC 42001

• SOC 2-aligned security and controls

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.

THE REGASK DIFFERENCE

RegASK is a purpose-built regulatory intelligence platform, combining proprietary AI agents, a global community of regulatory experts, and a curated regulatory content library.

It connects directly and seamlessly into enterprise workflows, enabling coordinated, governed execution across the product lifecycle.

Now available on Azure Marketplace for streamlined procurement, deployment, and billing through your existing Microsoft Azure commitments.

Learn more at regask.com.