New certification reinforces RegASK’s commitment to building a secure, transparent, and ethical AI solution as global demand for its platform surges.
RegASK, the AI-driven platform redefining regulatory intelligence and workflow orchestration for life sciences and consumer products organizations, has been certified to ISO/IEC 42001:2023 for its Artificial Intelligence Management System. This achievement makes RegASK the first vertical-specific regulatory intelligence platform to meet the international standard for AI governance, marking an important milestone for responsible AI in regulated industries.
The certification comes as RegASK experiences a more than 10x growth in AI usage on its platform over the last six months, signaling high adoption from life sciences and consumer products organizations globally. This milestone validates RegASK’s position as a trusted partner for organizations navigating complex regulatory environments and seeking to adopt AI with confidence.
ISO/IEC 42001:2023 is the world’s first global standard defining requirements for establishing, implementing, maintaining and continually improving an Artificial Intelligence Management System. It provides a structured framework to govern AI across its lifecycle with a focus on ethics, accountability, data protection, transparency, and human oversight.
The requirements set out in the standard reflect practices that have long guided RegASK’s approach to AI. The company applies strict governance principles across the design, training, deployment, and monitoring of its AI systems across its platform, aligned with the needs of the highly regulated sectors it serves. This includes comprehensive controls to ensure fairness, transparency, explainability, data protection, and safety, paired with human oversight that ensures every AI-generated insight is reliable, traceable, and consistent with global regulatory requirements.
“We are scaling our AI capabilities rapidly, but it is critical they are built the right way,” said Amenallah Reghimi, Chief Product and Technology Officer at RegASK. “This certification affirms the engineering rigor that underpins our systems. The market has validated our approach with incredible adoption rates, and we believe that trust must remain the foundation of every intelligent product. When AI is built responsibly, it becomes a force for progress.”
The ISO/IEC 42001:2023 certification adds to RegASK’s strong portfolio of existing security and privacy credentials, including:
- ISO 27001 (Information Security Management)
- ISO 27018 (Protection of PII in Public Clouds)
- SOC 2 Type II (Security, Availability & Confidentiality)
- GDPR Compliance (General Data Protection Regulation Compliance)
“ISO 42001 is more than a certification for us. It represents the future we are building. As organizations accelerate their use of AI, they need partners who can deliver innovation with accountability, and we are proud to stand among the pioneers defining what responsible AI should look like,” said Caroline Shleifer, Founder & CEO of RegASK.
The journey does not end here. RegASK will continue raising the standards that guide its AI capabilities and ensure they are developed and governed responsibly. This gives regulatory teams the certainty they need to rely on the platform for high-stakes decisions and regulatory readiness.
About RegASK
RegASK is an AI-driven platform enabling end-to-end regulatory intelligence and workflow orchestration. It automates regulatory intelligence with curated content, actionable insights, and workflow automation, while connecting a global community of over 1,700 subject matter experts for streamlined compliance execution. By combining Agentic AI efficiency with deep regulatory expertise, RegASK empowers organizations to proactively manage compliance and navigate complex regulatory landscapes with confidence. To learn more about RegASK visit regask.com.
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Reuben Chen
reuben.chen@regask.com