The AI system for modern regulatory teams — agentic speed, human confidence.
Every consumer product that crosses a border carries an invisible passport: a stack of rules governing what it can contain, how it must be labeled, and what claims it can make. Those rules change constantly, in dozens of languages, across scores of jurisdictions. For years, the people responsible for tracking them did so the hard way - refreshing government websites, copying updates into spreadsheets, and hoping nothing slipped through. RegASK was built to end that ritual.
Founded in Singapore in 2018 by Caroline Shleifer, RegASK is a regulatory technology company that treats compliance as a software problem. Its platform monitors regulatory change across more than 160 markets, assesses what each change means for a given product, and routes the resulting work to the right people. The company describes the result in plain terms: "speed from agentic AI, confidence from human expertise."
That phrasing is deliberate. RegASK is not selling a chatbot bolted onto a compliance database. It pairs autonomous AI agents - software that reads a rule change and takes the next step - with a global community of more than 1,800 regulatory experts who validate the judgment calls that machines should not make alone. In a field where a single missed update can stall a launch or trigger a recall, that human backstop is the point, not a footnote.
Shleifer did not arrive at the problem theoretically. She spent the early part of her career in regulatory affairs at global consumer-goods companies, watching her teams track thousands of regulatory changes across dozens of markets by hand. She holds a PharmD-PhD in Medical Physics from the University of Paris V, and before founding RegASK she led regulatory and scientific affairs across the Asia-Pacific region for an international medical-science consultancy. The company she built reflects that lineage: scientific rigor, regulatory fluency, and a low tolerance for manual busywork.
At its core, RegASK performs three jobs that used to be separate. First, it watches - continuously scanning more than 2,700 official publishers and building a library of over six million regulatory data points. Second, it interprets - using AI to summarize, translate across 120+ languages, and assess the impact of a change on a specific product or market. Third, it acts - orchestrating the tasks, alerts, and approvals that turn a regulatory update into a compliant decision. The company says the approach cuts the time teams spend tracking change by up to 70 percent.
In 2025 RegASK pushed that model further, launching what it called the industry's first agentic AI regulatory workflow orchestration solution. The distinction matters: earlier tools answered questions when asked, while agentic software carries out multi-step work on its own - reading a change, assessing impact, and assigning the follow-up. It is the difference between a reference book and a colleague.
As regulatory volume and fragmentation grew, manual monitoring, siloed tools, and shared drives stopped scaling. RegASK rebuilds regulatory affairs as a single operating system.
Continuous, automated monitoring of thousands of official sources so nothing depends on someone remembering to check a government website.
AI reads each change, summarizes it, translates it, and flags what it means for a specific product, market, or claim.
Agentic AI routes tasks, alerts, and approvals - turning a regulatory update into a defensible, documented decision.
An AI-native regulatory OS combining agentic AI, human expertise, and enterprise governance across 160+ markets.
Industry-first agentic AI that reads a change, assesses impact, and assigns the resulting tasks automatically.
Timely, actionable regulatory alerts with proactive task management for fast-moving regulatory change.
Augmented analytics that surface data-driven insights for product development, QA, and compliance.
Ask questions in natural language, with summarization and instant translation across 120+ languages.
Auditable, documented AI backed by ISO 42001, ISO 27001, SOC 2 Type II, and GDPR compliance.
Most RegTech aims at banks. RegASK went the other way - specializing in life sciences and consumer products, where the rules are scientific, the markets are many, and the penalties are physical.
Speed from agentic AI. Confidence from human expertise.— RegASK's operating principle
RegASK sells to regulatory and compliance teams at large life sciences, consumer products, and food & beverage companies. Its named customers span some of the world's most recognizable brands.
B2B SaaS. RegASK licenses access to its regulatory intelligence platform on subscription, layering an expert-network validation service and enterprise integrations - including Veeva RIM - on top. Roughly 83 employees support the product, with the 1,800+ expert community operating around it.
Caroline Shleifer starts RegASK to replace manual, spreadsheet-based regulatory tracking with software.
The platform expands automated monitoring and actionable alerts across life sciences and consumer products.
Round led by Monograph Capital, with SPRIM Global Investments, to accelerate global growth.
A conversational GenAI assistant, content summarization, and translation across 120+ languages arrive.
Industry-first agentic AI orchestration launches; RegASK becomes first in category certified to ISO/IEC 42001 amid 10x AI-usage growth.
RegASK connects its agentic intelligence to Veeva RIM, bringing regulatory AI into enterprise systems.
The question facing every compliance leader has shifted. It is no longer "should we use AI?" but "can we defend how we used it?" RegASK's entire design answers that second question. In November 2025 it became the first vertical-specific regulatory intelligence platform certified to ISO/IEC 42001 - the world's first standard for AI management systems - joining an existing portfolio that includes ISO 27001, ISO 27018, SOC 2 Type II, and GDPR compliance.
That credibility is the flywheel. In regulated markets, momentum tends to compound slowly and then quickly: a $10 million Series A in 2022, a 10x jump in platform AI usage across six months of 2025, and a partnership with Veeva that plugs RegASK into the systems large pharma teams already run. The company sits in a growing RegTech market, but on its own patch - the intersection of scientific regulation, global market access, and enterprise-grade AI governance - it has fewer direct rivals than the crowded financial-compliance corner.
What people can actually do with it is concrete. A cosmetics company entering a new market can see, in one place, what ingredients are restricted and what claims are allowed. A supplement brand can be alerted the moment a labeling rule shifts. A pharma regulatory lead can ask a question in plain language and get an answer grounded in current, localized rules - then hand the follow-up to an agent. The unglamorous work of staying compliant becomes, for once, something a team can see and steer.