Reading the rules, at machine speed
Regulation does not sleep. Every day, somewhere across 160-plus jurisdictions, an agency updates a label requirement, tightens an ingredient rule, or publishes a new standard for how a medical device can be sold. For a company shipping products across borders, missing one of those changes can mean a recall, a fine, or a market closed overnight. Caroline Shleifer spent years tracking those changes the slow way - by hand, across continents - and decided the work belonged to a different era.
Shleifer is the founder and CEO of RegASK, a Singapore-based company that describes itself as a global, AI-driven solution for curated regulatory intelligence. Founded in 2018, it combines a purpose-built AI engine with a community of more than 1,800 regulatory experts who validate the insights that still need human judgment. The pitch is deceptively simple: tell companies what changed in the rules that affect them, before it becomes a problem.
What makes the story unusual is where its founder started. Shleifer is not a career software executive. She trained as a pharmacist and earned a PharmD-PhD in medical physics from the University of Paris V, studying through the 1990s. Her background sits at the intersection of science, healthcare and law - the exact place where regulation is thickest and mistakes are most expensive.
From the lab bench to Asia Pacific
Before RegASK, Shleifer spent a long stretch at SPRIM, a healthcare-focused consulting and investment group. As part of the firm's early team she worked across a wide range of scientific and regulatory projects in the United States, China and the broader Asia Pacific region, along with digital health work in several countries. In 2011 she became Director of Regulatory and Scientific Affairs for APAC, later serving as head of regulatory and scientific affairs for Asia Pacific and Africa, and eventually as a partner at Sprim Ventures.
That vantage point - watching regulated products try to reach very different markets, each with its own rulebook - is where the idea for RegASK took shape. The problem she kept running into was not a lack of expertise. It was scale. A handful of specialists could read and interpret regulations beautifully, but they could not read fast enough or broadly enough to keep up with a world producing millions of regulatory data points a year.
The human-in-the-loop bet
Plenty of founders in 2018 would have pitched pure automation. Shleifer built something more careful. RegASK's model deliberately keeps people in the loop: the AI engine surfaces and organizes regulatory change, but human experts validate anything that requires judgment. In a domain where a wrong interpretation carries legal consequences, that combination is the whole point.
She has been consistent about this in public. Across podcast appearances and industry interviews, Shleifer returns to the same theme - that emerging technologies like AI, machine learning and data analytics are reshaping regulatory monitoring, but the goal is a more proactive approach to compliance, not a blind one. The technology should let people interpret regulatory information faster and more accurately, she argues, so that compliance teams stop reacting to yesterday's rules and start anticipating tomorrow's.
Scale, in numbers
The platform Shleifer has built now monitors more than 2,700 official publishers, tracks over 6 million regulatory data points, and covers upward of 160 territories. Its expert community numbers more than 1,800 subject matter specialists spread across the markets it watches. The company is headquartered at Singapore Science Park and runs operations across the United Kingdom, the United States, India and France.
The reach of RegASK
Recognition and momentum
The industry has taken notice. In 2025 Shleifer was named a Pro to Know by Supply & Demand Chain Executive, a recognition of leaders reshaping supply chain and compliance work - in her case, through AI-driven regulatory intelligence that helps organizations manage tangled global supply chain requirements with more confidence. RegASK has raised a $10 million Series A, with backers including Monograph Capital and SPRIM Global Investments, to fund its expansion.
More recently the company has leaned into agentic AI - governed workflows that can, for example, take a label compliance review that once took days and compress it to minutes, without abandoning the guardrails that keep the output trustworthy. Shleifer has continued to be a regular voice in the RegTech community, appearing on podcasts and in reports to talk about responsible AI in regulated industries and the annual state of regulatory affairs.
The through-line across all of it is a founder who understands the domain from the inside. Shleifer did the manual work first. She knows what a missed regulatory update costs, because she once was the person responsible for not missing it. RegASK is her attempt to give every compliance team the reach she wished she had - a system that watches everything, flags what matters, and still knows when to ask a human.
She is, by the record, an internationalist: fluent in French, English and Spanish, trained in Paris, seasoned across Asia, and now building from Singapore for customers worldwide. It is a fitting profile for someone whose product exists precisely because the rules are different everywhere you look.