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Frequently Asked Questions

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What is RegASK?

 

RegASK is the AI-driven agentic solution for regulatory intelligence and workflow orchestration.

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

RegASK reduces manual work and accelerates go-to-market timelines. 

RegASK a été présenté dans Gartner’s Market Guide for Regulatory Intelligence Solutions.

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Who is RegASK designed for?

 

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

RegASK supports organizations in life sciences and consumer goods by simplifying workflows and delivering timely insights to stay ahead of global regulatory changes.

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What makes RegASK different from other regulatory solutions?

Unlike static databases or general-purpose AI tools, RegASK combines:

•The 1st dedicated vertical LLM fine-tuned on industry-specific regulatory data to deliver deep, contextual insights.

AI-driven regulatory agents that orchestrate workflows and support informed, confident decision-making.

• An integrated access to a curated community of regulatory experts across 120+ markets.

A hybrid model that augments human expertise, enhancing regulatory professionals, not replacing them.

• A seamless integration through APIs and Agent to Agent.

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What industries does RegASK serve?

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

Sciences de la vie 

  • Pharmaceutique et biotechnologie 
  • Medical Devices & Medtech 
  • Consumer Health and OTC
  • CRO

Produits de consommation      

  • General Food & Beverage 
  • Dietary/Health Supplements
  • Préparations pour nourrissons et aliments pour besoins spéciaux
  • Ingrédients
  • Animal Health and Nutrition
  • Cosmetics and Personal Care
  • Skincare, Hygiene and Haircare
  • Appareils de beauté
  • Santé bucco-dentaire                                                            
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What problems does RegASK solve? 

RegASK helps teams: 

  • Stay ahead of changing global regulations 
  • Speed up market entry and product launch timelines 
  • Reduce compliance costs 
  • Improve audit readiness and documentation 
  • Eliminate manual tracking across markets 
  • Improve collaboration 
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What makes RegASK different from traditional regulatory consultancies? 

Unlike traditional consultancies, RegASK combines AI automation with domain expertise. Our hybrid model delivers: 

  • Faster insights 
  • Standardized, scalable outputs 
  • Continuous regulatory monitoring 
  • Expert-validated reports in 120+ markets 
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How does RegASK’s AI engine work?

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.

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What is a regulatory AI agent?

UN 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.

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Is RegASK compliant with data privacy and security standards?

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

All data is 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.

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Can RegASK support multilingual or regional regulatory needs?

 

Yes, 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, APAC (Japan, China, Australia, Singapore etc) and GCC.

Combined with a global expert community, RegASK ensures accurate, region-specific compliance across your product lifecycle.

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What outcomes can companies expect from using RegASK?

RegASK delivers measurable improvements across regulatory operations. Companies can expect:

Up to 70% reduction in manual regulatory tasks,
Accelerated speed to market,
Improved regulatory foresight and risk mitigation,
Greater collaboration between local and global regulatory affairs teams.

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Does RegASK replace regulatory experts?

No. RegASK is not designed to replace regulatory professionals. RegASK is built to augment them.

As an AI-driven agentic solution, RegASK automates repetitive tasks, streamlines workflows, and delivers curated insights so regulatory teams can focus on high-value activities like strategy, risk assessment, and decision-making. The result is smarter, faster compliance, powered by both human expertise and intelligent automation.

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What awards and recognition has RegASK received?

RegASK has been featured in the 2024 Gartner Market Guide for Regulatory Intelligence Solutions and named among the Top AI 50 global innovators. Our leadership has also been recognized:

  • Amern Reghimi et Caroline Shleifer were named in the Top 50 AI Leaders in Procurement.
  • We are proud to partner with AWS, NVIDIA, and Google, reinforcing our AI-driven approach to regulatory intelligence and workflow orchestration.
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How do I get started with RegASK?

 

You can request a demo or speak with one of our regulatory solutions consultants by visiting the Contact Us page ou booking a demo with our team.