The AI Operating System for Life Sciences

The infrastructure to orchestrate work between humans and AI.

Bringing therapies and medical technologies to patients requires thousands of interconnected decisions, documents, handoffs, and controls. AI can dramatically expand what organizations are capable of — but only if the work remains governed, traceable, and accountable.

  1. Expand capacity across regulated work without adding human headcount at the same rate.

  2. Maintain control, evidence, traceability, and auditability across every human + AI interaction.

  3. Shift repeatable, document-heavy work to AI while preserving scientific judgment, expert review, and human accountability.

  4. Coordinate people and AI agents across regulated workflows, handoffs, reviews, and approvals.

MineSimulateOrchestrate

Asteri builds specialized agents for regulated Life Sciences workflows, grounded in enterprise context and designed to operate with human oversight and controls. Deploy Asteri agents or govern third-party agents through the same operating layer. Asteri goes deepest today in Regulatory Affairs, Clinical Operations, and Quality.

Regulatory Affairs

Regulatory intelligence, submissions and lifecycle work.

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Clinical Operations

Study startup, trial execution, Trial Master File and clinical documentation.

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Quality

Controlled Quality work including documentation and change-related activities.

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Julia SamoylenkoFounder & CEO

I spent over a decade at Medtronic, leading some of the largest transformation initiatives the company had undertaken.

I saw firsthand how complex regulated work really is — not in theory, but in the daily reality of thousands of knowledge workers navigating processes no system was built to handle. That experience is what inspired me to build Asteri.

AI is now entering that structure faster than most enterprises can govern it.

We’re building more than a product. Alongside Pharma, MedTech, and BioTech leaders, we’re defining a new standard for how regulated work gets done. A future where AI complements expertise, where compliance is a property of the system rather than a checklist, and where every team operates at the limit of what science — not headcount — allows.

Explore the Platform.

See how Asteri brings work intelligence, capacity planning, and governed orchestration together to run human + AI work at scale.

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Make AI part of the operating model.

Humans and AI agents. One governed workforce.