Zoentia One Pharma

One AI platform.
Built for Pharma.

Governed intelligence layers for regulated Life Sciences.

Pharma Intelligence

Engineered for
Life Sciences.

Built around how Pharma works: clinical, regulatory, quality, safety, medical and manufacturing knowledge — understood in context.

Connected Intelligence

One intelligence platform
across your organization.

Connect your data, systems and knowledge in Zoentia One Pharma.

Zoentia One Pharma

Accelerate your
pipeline.

Automate and accelerate work across your pharmaceutical organisation.

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The Platform

One governed operating layer.

Govern every AI system, capture the evidence it produces, and map it to every regulation — in one place.

Build01 · Core

One Core

The AI infrastructure connecting your models, agents, knowledge and enterprise systems.

  • Models
  • Agents
  • RAG
  • MCP
  • APIs
  • SDK
  • Workflows
  • Connectors
  • Tools
  • Long-term Memory
  • Hyper-Personalization
Use02 · Assistant

One Assistant

A secure AI assistant that understands approved pharmaceutical knowledge and can perform authorized actions.

  • Chat
  • Voice
  • Knowledge
  • Actions
  • Search
  • Citations
  • Documents
  • Approvals
  • Memory
  • Context-Dialog
  • Interruptible-Reasoning
Govern03 · Suite

One Suite

One place to govern AI systems, agents, workflows and evidence across the organization.

  • Governance
  • Policies
  • Permissions
  • Monitoring
  • Evidence
  • Audit
  • Project Memory
  • Tenant-Workspace

See the platform in motion

03 · Governance

Enterprise AI,
governed by design.

Every action is policy-checked, human-approved where it matters, and captured as audit-ready evidence — built into the platform, not bolted on afterwards.

01 · Policy

Checked before action.

Policies, permissions and operational boundaries travel with every model, agent and workflow.

02 · Oversight

Human judgment, where it matters.

Critical decisions pause for the right reviewer without slowing down the work that can safely move.

03 · Evidence

Audit-ready by default.

Every source, model, tool, decision and approval becomes a traceable evidence record automatically.

One Suite · Governance operating layer
01 · ClassifyUnderstand the risk.

Inventory the AI system, intended use, data, owner and regulatory context before work begins.

02 · ControlDefine how AI may operate.

Attach policies, permissions, approved knowledge and human-review gates to the workflow itself.

03 · ExecuteMove safely inside the boundaries.

Models, agents and teams operate within approved controls without recreating governance at every step.

04 · EvidenceCapture proof while work happens.

Sources, versions, decisions and approvals become reusable records for review, submission and inspection.

Governance coverage

One controlled record,
end to end.

ClassifyControlExecuteEvidence
AI inventory and risk classification
Approved data and source provenance
Model, version and context of use
Human oversight and approval gates
Audit trail and electronic records
Monitoring, change control and revalidation

European operating context

Prepare evidence across the EU AI Act’s horizontal risk obligations alongside GxP, Annex 11, MDR/IVDR and data-integrity controls.

United States operating context

Map the same controlled record to FDA expectations around context of use, model credibility, lifecycle management and 21 CFR Part 11.

AI Evidence Record Example
  • Source
  • Model
  • Version
  • Context
  • Agent
  • Tools
  • Decision
  • Human approval
  • Timestamp
Evidence IDZOENTIA-ONE-PH-84721
Evidence generated as work happens

Every action.
Traceable.

Sources, model versions, tools, decisions and approvals assemble into one inspection-ready record as you scroll.

Designed for regulated AI environments EU AI Act · GxP · Annex 11 · 21 CFR Part 11 · MDR / IVDR · Context of Use · Model Credibility · Data Provenance · Human Oversight · Audit Trails · Change Control · Lifecycle Monitoring
Zoentia One Pharma
Powered by Zoentia One

Move faster through
regulated work.

Reduce manual review, reuse approved knowledge and turn every AI-assisted action into evidence your regulatory, quality and safety teams can trust.

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