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RegASK

Also known as: RegGenius, Action Hub, ActionHub

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Entry priceContact for pricingFull pricing detail

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 an agentic AI regulatory intelligence platform for life sciences and consumer products companies, used by regulatory, quality, safety, pharmacovigilance and labeling teams at organizations including Unilever, Nestle, Ajinomoto, Ferrara and iNova.

It monitors regulatory authorities and official sources across more than 160 markets in near real time and raises alerts tagged by impact on the customer's own products and markets, turns signals into leadership ready insights and trend foresight, and lets a team assess what each change means for products, markets and submissions with agents that translate, summarize, triage and structure regulatory content at scale.

RegGenius, the platform's assistant, answers regulatory questions in natural language with live, contextual responses and full source citations drawn from a curated library of more than six million regulatory data points and from Vault, the customer's own workspace of source documents, internal procedures and guidances.

ActionHub is the command center from which a team tracks change, assigns tasks, manages workflows and timelines and triggers actions, with every action controlled through structured workflows and role based approvals and traced through a complete audit trail; a community of more than 1,800 regulatory practitioners across those markets is available for local deep dives, validation and dossier ready submissions when the work calls for human judgment.

RegASK delivers structured assessments into Veeva Vault RIM, connects label compliance review to Esko artwork workflows, and connects to other enterprise systems through an API, agent to agent coordination and MCP. It is certified to ISO 27001, ISO 27018, ISO 27701, ISO 42001 and SOC 2 Type II, ships SAML and OIDC single sign on, SCIM provisioning, role based access and immutable audit logs, hosts on Microsoft Azure with regional hosting options, and is sold by demo or through Microsoft Marketplace.

Vendor details

Canonical URL

https://regask.com

Category

Enterprise operations agent

Funding status

Series A. Caroline Shleifer is co founder and CEO, and Amenallah Reghimi is CPTO. The company is based in New York and Singapore and is certified to ISO/IEC 42001:2023.

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

Delivers structured assessments into Veeva Vault and Veeva RIM and connects label compliance review to Esko artwork workflows. Connects to other systems through an API, agent to agent coordination and MCP, with prebuilt connectors, enterprise SSO, and links to document management systems and eCTD submission platforms. No API reference documentation is published.

Agentic Index coverage score

8.5 / 14 capabilities · 61%

Integrations & Tool Calling Full

RegASK names integrations that act in the customer's systems. Structured assessments and prioritized actions are delivered into Veeva Vault RIM as the customer's system of record. An Esko integration lets a label compliance finding update the artwork workflow. The platform overview describes delivery of structured outputs into QMS, labeling and product lifecycle workflows, and an API routes intelligence into quality systems and orchestration workflows. No framework for customers to add their own tools is documented, and the catalog is short.

SourceRegASK, regask.com/partnerships-and-integrations and regask.com/productread 2026-09-06

Workflow Orchestration Full

The platform overview documents structured workflows that assess impact, assign tasks and manage execution with timelines. ActionHub is a command center from which changes are tracked and actions triggered. Agents translate, summarize, triage and structure regulatory content so a change moves from signal to assessment to coordinated action. That is multi step execution with a customer facing workflow surface.

SourceRegASK, regask.com/productread 2026-09-06

Knowledge Grounding & RAG Full

RegGenius answers are grounded in a curated, continuously maintained regulatory content library of more than six million data points across 160 markets, filtered to the customer's products, markets and risk areas. They also draw on Vault, the customer's own workspace holding source documents, internal SOPs and external guidances. Answers come back as live, contextual responses with full source citations. Both the vendor's corpus and the customer's own knowledge persist and stay queryable.

SourceRegASK, regask.com/productread 2026-09-06

Human Oversight & Guardrails Full

The platform overview documents governance in which every regulatory action is controlled, approved and accountable through structured workflows and role based controls. The security page states human in the loop controls keep regulatory experts in the decision path under the ISO 42001 framework. The approval workflow is the vendor's own mechanism. The community of 1,800 experts who validate critical insights on demand is human expertise the customer engages, not a platform control.

SourceRegASK, regask.com/product and regask.com/securityread 2026-09-06

Security, Identity & Governance Full

RegASK's security page documents both compliance and access controls. It lists independently audited certifications to ISO 27001, ISO 27018, ISO 27701, ISO 42001 and SOC 2 Type II, with GDPR compliance. The customer facing access controls are SAML and OIDC SSO, SCIM provisioning, role based access control, scoped API keys and IP allow listing. Audit reports and control evidence sit in a trust center shared under NDA.

SourceRegASK, regask.com/securityread 2026-09-06

Observability & Auditability Full

The security page documents comprehensive admin and data access logs with immutable trails. The platform overview documents traceability of every signal, decision and change through a complete audit trail maintained across systems and workflows. Every assistant answer carries full source citations.

SourceRegASK, regask.com/security and regask.com/productread 2026-09-06

Memory & State Persistence Not documented

RegGenius is a conversational assistant, yet no conversation state within or across sessions is documented, and no memory layer with a stated scope and lifetime is described. The customer's products, markets and risk areas that tailor alerts, and the Vault holding its source documents and SOPs, are the customer's knowledge and profile rather than agent memory. The regulatory content library is the vendor's corpus.

SourceRegASK, regask.com/productread 2026-09-06

Deployment & Data Residency Partial

The security page states regional hosting options aligned to the customer's jurisdiction, with a transparent sub processor inventory, and its FAQ names Microsoft Azure as the hosting platform. Beyond that one statement, no region list, customer cloud, on premises or customer tenant option, or way to choose a region is documented, and the sub processor inventory that would name regions is shared under NDA.

SourceRegASK, regask.com/securityread 2026-09-06

Prebuilt Agents / Templates / Packs Partial

The platform overview presents Alerts, Insights, RegGenius, ActionHub and Vault as capabilities of one operating system a customer buys whole, not as products adopted separately. The agents that translate, summarize, triage and structure regulatory content are the vendor's own machinery, which the customer never selects. These are features of one platform rather than separately adoptable products, and no catalog of prebuilt packs is published.

SourceRegASK, regask.com/productread 2026-09-06

Triggers & Channel Coverage Full

Detected regulatory change is what sets the platform to work. Near real time monitoring across more than 160 markets raises alerts tagged by impact on the customer's products and markets. ActionHub tracks the change and triggers the downstream actions, with structured outputs delivered into Veeva RIM and other systems. Besides those event driven starts, work comes in through the web application, the RegGenius assistant and MCP access from a customer's copilot. No customer configurable schedule or webhook surface is documented.

SourceRegASK, regask.com/product and regask.com/partnerships-and-integrationsread 2026-09-06

Model Flexibility & Routing Not documented

The security page states model usage is restricted to approved model providers, in the plural, each backed by a documented risk assessment under ISO 42001. It also states customer data never trains a model. No provider is named, and no customer or admin model selection or per task routing is documented. The sub processor inventory that names providers is shared under NDA.

SourceRegASK, regask.com/securityread 2026-09-06

APIs / SDKs / MCP Extensibility Partial

The integrations page states RegASK connects through an API that routes regulatory intelligence into dashboards, quality systems and orchestration workflows, through agent to agent coordination, and through MCP into compatible copilots and agent environments. The security page names scoped API keys among its controls, so an API for the platform exists.

No reference documentation, endpoint list, SDK or agent card is published, the product page's "Explore integrations and APIs" link is an empty anchor, and there is no developer site. Agent to agent support without a published agent card is a claim rather than a documented interface.

SourceRegASK, regask.com/partnerships-and-integrations and regask.com/securityread 2026-09-06

Testing, Debugging & Optimization Not documented

No customer facing evaluation harness, test cases, quality gate or optimization loop for the workflows a customer configures is documented. Expert validation of critical insights is a human gate on outputs. The ISO 42001 management system with documented model risk assessments is the vendor's own release practice. The static and dynamic testing named under secure development is software assurance rather than agent evaluation.

SourceRegASK, regask.com/security and regask.com/productread 2026-09-06

Browser / Computer-use Not documented

RegASK is used through its web application, the RegGenius assistant and integrations into the customer's systems. Its continuous monitoring of regulatory authorities across 160 markets builds the content library the platform later queries, which is ingestion rather than computer use at run time. The Esko label review works on artwork delivered through an integration. No browser, desktop or computer control is documented.

SourceRegASK, regask.com/product and regask.com/partnerships-and-integrationsread 2026-09-06

The Agentic Index coverage score grades every vendor Full, Partial or Not documented against the same 14 buyer facing capabilities, from public evidence only. Each capability links to how all vendors in the index score on it. How this evidence is graded

Recent platform changes

2026-08-25·Workflow orchestrationVerified

RegASK launched an updated RegGenius Workspace, a governed AI environment that consolidates regulatory research, analysis, and reporting. The workspace allows teams to scope projects to specific regulatory alerts and documents, analyzing them in context while maintaining a connected trail of sources. It also enables users to generate cited deliverables like briefings, spreadsheets, and PDFs directly from their analysis.

Bears on: Workflow orchestration

View source
2026-07-21·Workflow orchestrationVerified

RegASK introduced an end-to-end agentic AI label compliance workflow that transitions product labels from draft to market-ready compliance in a single governed system. The workflow replaces manual reviews with an AI first pass and expert-in-the-loop confirmation, checking label elements against target market requirements and routing follow-up actions to specific owners.

Bears on: Workflow orchestration

View source
View all 2 changes for RegASK →Tracked since Jul 2026 · Verified from public vendor sources

Pricing

Contact for pricing

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.

Agentic Index verified 2026-09-06

Alternatives to RegASK

The closest documented capability profiles to RegASK among enterprise operations agents tracked by Agentic Index, ordered by similarity on the same 14 point evidence the rankings use. No vendor pays for placement.

  • Basis7.5 / 14A lighter documented profile than RegASK
  • Byron8.5 / 14Adds documented Memory & State Persistence
  • RedOwl8.5 / 14Adds documented Testing, Debugging & Optimization
  • Tabs8.5 / 14Fuller documented coverage on APIs, SDKs & MCP Extensibility
  • Vic.ai7.5 / 14A lighter documented profile than RegASK
  • Workable8.5 / 14Fuller documented coverage on APIs, SDKs & MCP Extensibility

Similarity is computed from each vendor's Agentic Index coverage score evidence, axis by axis, not from the totals. How this evidence is graded

Head to head

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