Frequently Asked Questions

RegASK is GDPR-compliant and certified under internationally recognized standards, including ISO 27001 and SOC 2 Type 2.

All data are encrypted in transit and at rest, access is strictly role-based, and the platform is hosted on secure Microsoft Azure infrastructure.

For Life Sciences clients, RegASK aligns with GxP and other relevant industry-specific security frameworks where applicable.

RegASK reduces manual work and accelerates go-to-market timelines, driving efficiency, accuracy, and business value.

Our AI-driven regulatory intelligence platform automates monitoring global regulations, surfaces actionable insights, and provides guidance on next steps.

This means regulatory teams spend less time searching and compiling data, and more time making strategic decisions. By streamlining compliance with workflows, RegASK helps companies stay ahead of regulatory changes, launch products faster, and expand confidently into new markets.

RegASK eliminates manual regulatory monitoring, fragmented workflows, and slow go-to-market. The platform uses AI-driven regulatory intelligence and agents to:

– Reduce manual work by automating global regulation tracking and change detection
– Stay ahead of changing global regulation
– Cut uncertainties with actionable insights and next-step guidance
– Break information silos by centralizing requirements, evidence, and decisions
– Lower compliance risk and costs through continuous monitoring and audit-ready traceability
– Scale to new markets faster with localized, multi-country coverage
– Improve audit readiness and documentation

Result: faster launches, greater predictability, and regulatory teams focused on strategy instead of repetitive tasks.

RegASK’s AI-driven engine, RegGenius, is built on vertical, domain-specific models that:

– Continuously monitor global regulatory updates with timely, curated intelligence
– Automate workflows and streamline end-to-end regulatory operations
– Summarize and translate local regulations into actionable insights
– Support regulatory pathway analysis and generate draft documents

Powered by a multi-agent architecture, RegGenius performs Q&A, summarization, and document analysis in parallel enhancing both speed and precision.

RegASK is designed for teams working across Regulatory Affairs, Compliance, Risk Management, Quality Assurance, and Pharmacovigilance.

RegASK empowers regulatory affairs, compliance and risk, quality and pharmacovigilance teams with smart documentation, curated alerts, and actionable insights.

RegASK supports organizations in Life Sciences and Consumer Goods by simplifying workflows and delivering timely insights to stay ahead of global regulatory changes.

You can request a demo or speak with our sales team by visiting the Contact Us page or booking a demo.

The platform is hosted on secure cloud infrastructure, complies with GDPR and follows best practices for data protection. Confidential client information is safeguarded through encryption and strict access controls.

This ensures that sensitive regulatory and product data remain protected while teams benefit from automation and intelligence.

A regulatory AI agent is a specialized, AI-driven software system designed to perform key compliance tasks such as:

– Monitoring and interpreting timely regulatory updates
– Answering compliance-related questions
– Assisting with regulatory submission planning and deadline tracking

RegASK leverages a multi-agent architecture to deliver contextualized support across the regulatory lifecycle. RegASK enhances decision-making, reduces manual effort, and accelerates time-to-market.

RegASK supports multilingual and regional regulatory needs.

RegASK’s AI-driven engine offers instant translation in 120+ languages and delivers localized insights tailored to specific markets, including United States, Canada, South America, EU, UK, APAC (Japan, China, South Korea, Australia, Singapore etc) and GCC.

RegASK serves two industries in highly regulated industries, namely Life Sciences and Consumer Products including:

Life Sciences
– Pharma, BioPharma & Biotech
– Consumer Health
– Medical Devices & Medtech
– CRO

Consumer Products
– General Food & Beverage
– Dietary and Health Supplements
– Infant Formula and Food for Special Needs
– Food Ingredients
– Animal Health and Nutrition
– Cosmetics and Personal Care
– Hygiene and Haircare
– Beauty Devices
– Oral Health

RegASK’s pricing is tailored to each customer’s needs. To receive a customized proposal, please contact our Sales team.

RegASK’s Customer Success team partners with clients from day one, starting with a strategic kickoff to align goals and challenges. We ensure fast onboarding with credentials shared within an hour and a calibration session within 30 days.

We drive ongoing value through monthly touchpoints that track adoption, progress, and share updates on new features, supported by training resources and videos. Clients also have access to a robust self-service help center and responsive ticket-based support, ensuring seamless and confident platform use throughout the partnership.

No, RegASK does not replace regulatory professionals. It augments their capabilities and empowers them.

The platform automates manual monitoring, tracks global regulatory changes, and delivers actionable insights so regulatory teams can focus on higher-value work. The result is smarter, faster compliance, powered by both human expertise and intelligent automation.

Instead of spending hours on repetitive compliance tasks, regulatory teams use RegASK to accelerate go-to-market timelines, reduce compliance risk, and make faster, evidence-based decisions.

RegASK delivers measurable ROI by reducing compliance costs, minimizing delays, and accelerating product approvals. Customers report significant time savings from automated monitoring, faster regulatory intelligence turnaround, and improved success rates in product launches.

By avoiding delays and compliance risks, organizations see stronger margins and faster market entry.

Yes, RegASK has been recognized by leading industry analysts. In 2024, RegASK was featured in the Gartner Market Guide for Regulatory Intelligence Solutions, the first key industry report reviewing top vendors in the emerging regulatory intelligence software space.

This report highlights the capabilities required for effective regulatory intelligence and underscores the growing demand for AI-driven solutions to manage complex regulatory changes.

RegASK’s inclusion demonstrates its strength in:

– Content curation and aggregation
– Regulatory change management
– AI-enhanced insight delivery

RegASK offers on-demand access to regulatory experts through its Ask RegASK service, available directly via the platform. You can engage our experts through an annual subscription to extend your team’s capacity or as an ad-hoc service alongside your platform subscription.

Our team can help you customize the level of expert support to match your regulatory strategy, timelines, and regional priorities.

Yes, RegASK’s Customer Success team delivers customized onboarding that emphasizes platform enablement and aligns use cases with feature adoption to resolve identified pain points.

RegASK integrates intelligence into existing workflows, so insights move directly into the hands of regulatory, quality, pharmacovigilance and product teams. Dashboards and alerts ensure that updates are actionable and prioritized.

This creates efficiency across functions and reduces the bottlenecks that slow product launches.

RegASK is proud to partner with technology partners such as AWS, NVIDIA, and Google, reinforcing our AI-driven approach to regulatory intelligence and workflow orchestration.

We also collaborate with trusted distribution partners, such as Matsumoto in Japan, to expand global reach and deliver localized regulatory support.

Yes, in addition to onboarding sessions, RegASK’s Customer Success team proactively shares updates on new product releases and capabilities, providing training materials and videos to help your team leverage enhanced functionality as it becomes available.

RegASK does not offer free pilots. Most of our clients deploy RegASK through a yearly subscription; however, in certain cases, a pilot may be discussed prior to full deployment.

RegASK has been recognized as a leading company in the AI RegTech space. We have been featured in the and named as one of the Top 50 Thought Leading Companies for Generative AI 2025. We’re also honored to be recognized for the second consecutive year as one of the Top 50 Thought Leading Companies on Artificial Intelligence by Thinkers360, and received a recognition as one of 2025 Global Tech Award Winners in RegTech category.

RegASK adopts a hybrid pricing model based on yearly subscriptions and coverage.

RegASK has been featured in major industry publications and media outlets, including The Wall Street Journal and Bloomberg.

Yes, SME packages are available.

RegASK’s leaders have been honored for their impact in the AI and compliance ecosystem. Caroline Shleifer and Amenallah Reghimi were also recognized as 2025 Pros to Know by Supply & Demand Chain Executive, highlighting their expertise and thought leadership in the regulatory intelligence space.

RegASK regularly participates in industry conferences such as RAPS Convergence.

You can check out our section “News” to learn more about our latest and future events.

RegASK is a leading AI-driven regulatory intelligence and workflow orchestration platform, empowering global organizations in highly regulated sectors, including Life Sciences and Consumer Products, to proactively navigate complex regulatory landscapes.

Leveraging GenAI and advanced Agentic AI, RegASK provides proactive monitoring, actionable insights and end-to-end workflow automation, streamlining compliance processes, mitigating risks, and accelerating go-to-market timelines across over 150+ countries. We drive efficiency, accuracy, and business value.