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RegASK

Also known as: RegGenius, Action Hub

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Enterprise operations agentindependentVerified 2026-07-08

Agentic AI regulatory intelligence platform for life sciences and consumer products, with a network of specialized agents that triage regulatory change and orchestrate compliance workflows.

RegASK is a vertical agentic AI platform for regulatory affairs and compliance in life sciences and consumer products. It runs a network of specialized AI agents (research, impact assessment, translation, summarization, assessment generation, stakeholder communication) coordinated by a project manager agent that assigns and sequences tasks for collaborative multi step execution. The platform pairs a domain specific vertical large language model, trained on millions of regulatory data points, with bring your own content RAG and a global regulatory database that tracks each regulation across its full lifecycle. Horizon scanning spans 160 plus markets, feeding triaged RegAlerts, contextual impact analysis against a company's products, ingredients, claims, and markets, and an Action Hub command center. Enterprise grade governance, structured approval controls, and full audit traceability are embedded into every workflow, and the platform connects a global community of 1,800 plus subject matter experts. It is ISO/IEC 42001:2023 certified and hosted on Microsoft Azure.

Vendor details

Canonical URL

https://regask.com

Category

Enterprise operations agent

Funding status

Series A per public funding signals. Co-founder and CEO Caroline Shleifer; CPTO Amenallah Reghimi. New York and Singapore. ISO/IEC 42001:2023 certified. Featured in the Gartner Market Guide for Regulatory Intelligence Solutions (2024).

Company status

independent

Use cases & customers

Primary use cases

regulatory intelligencecompliance workflow orchestrationregulatory horizon scanninglabel compliance reviewregulatory impact assessment

Target customers

enterpriselife sciencesconsumer productsregulatory affairs teams

Deployment options

SaaS

Integrations

Open API, MCP support, Agent to Agent interactions, pre-built connectors, enterprise SSO, Veeva Vault, Veeva RIM, Esko, document management systems, and eCTD submission platforms.

Capability coverage

10.0 / 14 capabilities · 71%

Integrations & Tool CallingHome page and AI info page document an open API, pre-built connectors, enterprise SSO for Veeva Vault and Esko, Veeva RIM integration, and compatibility with document management systems and eCTD submission platforms. Full
Workflow OrchestrationJul 2025 architecture release describes specialized agents each performing a distinct task, coordinated by a dedicated project manager agent that assigns and sequences work for collaborative multi step execution, plus end to end regulatory workflow orchestration and task management. Full
Knowledge Grounding & RAGUses a domain specific vertical LLM trained on millions of regulatory data points, supports bring your own content RAG, and grounds analysis in a global regulatory database that tracks each regulation across its full lifecycle plus the customer's products, ingredients, claims, and markets. Full
Human Oversight & GuardrailsApr 2026 release embeds enterprise grade governance and structured approval controls into every regulatory workflow, connecting regulatory detection, human decision making, and enterprise execution. A subject matter expert verification layer validates AI outputs. Full
Security, Identity & GovernanceCertified to ISO/IEC 42001:2023 for AI governance, hosted on Microsoft Azure with encryption and Microsoft Defender surveillance, and offers enterprise SSO. Described as the first vertical regulatory intelligence platform to meet the AI management system standard. Full
Observability & AuditabilityApr 2026 release adds full audit traceability, and the Action Hub provides complete visibility and accountability across the organization. Home page lists a full audit trail. Full
Memory & State PersistenceMaintains persistent organizational context (products, ingredients, claims, markets, internal rules) and a global regulatory database with a chronological view of each regulation's lifecycle. No general agent memory construct is separately documented. Partial
Deployment & Data ResidencyDelivered as a cloud SaaS platform hosted on Microsoft Azure, web accessible with a mobile responsive interface. No on premise or explicit data residency options are documented on the retrieved pages. Partial
Prebuilt Agents / Templates / PacksShips an expanding network of prebuilt specialized regulatory agents (research, translation, summarization, assessment generation, label review) plus prebuilt modules such as RegAlerts, RegGenius, and the Action Hub command center. Full
Triggers & Channel CoverageContinuous horizon scanning across 160 plus markets drives workflow triggering agents and prioritized RegAlerts, with near real time integration into enterprise compliance systems so regulatory changes activate downstream tasks automatically. Full
Model Flexibility & RoutingThe platform runs a proprietary vertical large language model and custom models tuned to regulatory work. No customer selectable model or multi provider routing is documented on the retrieved pages, though MCP and A2A interoperability are supported. Unable to verify
APIs / SDKs / MCP ExtensibilityProvides an open API, documented MCP support and Agent to Agent interactions, pre-built connectors, and API access for connecting internal data lakes and analytics tools. Full
Testing, Debugging & OptimizationA human subject matter expert layer validates outputs, but no agent testing, evaluation harness, or self healing capability is documented on the retrieved pages. Sources note limited explainability requiring human interpretation. Unable to verify
Browser / Computer-useNo browser automation or general computer use capability is documented. The AI assisted label review uses an interactive artwork viewer, which is not browser or operating system automation. Unable to verify

Recent platform changes

No recent material changes tracked yet.

Pricing

Contact sales; no public pricing. Entry is a requested demo.

enterprise seats and modules (not disclosed)

Contact onlyMedium variable cost

Cost watchouts

Integration and configuration effort for eCTD, RIM, and internal data lakes may add implementation cost. Scope expands with markets and modules.

Variable cost rationale

Enterprise platform likely scoped by seats, modules, and markets covered. No public rate card, so variable exposure cannot be pinned precisely, but it is a subscription platform rather than pure usage billing.

Sales call required

Yes — required for paid access

Free / trial

No free tier; demo on request

Lowest paid plan

Not public

Key ambiguities

No public pricing at any tier. Contract structure, seat model, and module packaging are not disclosed.

Verified 2026-07-08

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