AI Transformation · Pharma and life sciences
For pharma, biotech, medtech and diagnostics companies: agents that draft regulatory documents, take in adverse event reports and answer medical information queries, alongside AI for quality, clinical operations and commercial teams, with validation and sign-off on every regulated output.
Where AI helps first
Every agent action approved by a named person
Written for
Heads of regulatory affairs, Heads of pharmacovigilance and medical affairs and Heads of quality and compliance
The question you came with
Why do regulatory submissions and safety reports still take weeks of manual work and review?
Part of Enterprise AI Transformation
Where it starts in life sciences. The first work handed to agents: regulatory document drafting, pharmacovigilance case intake and medical information agent. Each one drafts or flags, and a named person approves.
See the whole programmeIf two of these are true, the rest of this page is about you.
What it costsSubmissions slip, and experts spend weeks on formatting and consistency.
What changesAgents draft sections from source data and check consistency across documents for regulatory writers to finalise.
Agentic OS · AgentsWhat it costsCase intake backlogs, and reporting deadlines at risk.
What changesReports read, triaged and pre-filled into the safety database for a safety specialist to confirm.
Agentic OS · SignalWhat it costsHealthcare professionals get slow, inconsistent answers.
What changesQueries answered from approved content with sources, and anything off-label sent to medical affairs.
Agentic OS · FlowWhat it costsDeviations and CAPAs close late, and audits are a scramble.
What changesDeviations, CAPAs and training records tracked in one place, with overdue items flagged.
Agentic OS · PulseWhat changes for each of the people who sign off.
Faster, consistent submissions.
Case intake and medical queries without the backlog.
Validated systems and audit-ready records.
The capability on the left, what your team would notice on the right.
Submission sections, variations and responses drafted from source data, with cross-document consistency checks.
Adverse event reports from email, calls and literature read, coded and pre-filled for safety specialists to assess.
Questions from healthcare professionals answered from approved content with sources, and off-label queries routed to medical affairs.
Deviations, CAPAs, change controls and training records tracked in one place, with overdue items flagged.
Trial master file documents checked for completeness, versions and signatures.
Tender notices, formulary decisions and account plans tracked for commercial and market access teams.
The same programme runs in operations, finance and service. These are the first workflows we usually see handed to agents. Each one drafts, checks or flags; a named person decides.
Submission sections drafted from source data and checked for consistency, for regulatory writers to finalise.
Adverse event reports taken in and pre-filled for safety specialists to assess and confirm.
Medical information queries answered from approved content, with off-label questions routed to a person.
Deviations, CAPAs and training records tracked, with audit evidence collected as work happens.
Tenders, formulary decisions and account plans tracked, with contracts checked against your standard terms.
Small, fixed and useful on its own. You decide after each step.
Regulatory, safety, quality and systems reviewed, with your quality team, and the first workflows ranked by value and validation effort.
One agent live on approved content or incoming reports, validated for its intended use, with a baseline.
Submission drafting and CAPA tracking, on validated, in-region infrastructure.
Yes, when it is validated for its intended use, controlled and audited. We build validation evidence, audit trails and human sign-off into each agent, aligned to your quality system.
No. They take in and pre-fill cases. Safety specialists assess and confirm every case.
Data stays in your systems and region, on infrastructure you control, with private models where public AI services are not allowed.
With the AI Transformation Review. It ranks the first workflows by value and by the validation effort each needs.
Fixed-scope offers that fit this industry. Each has a set timeline and a deliverable you keep.
An assistant that answers from your own policies, SOPs and contracts, with sources, in your languages
A signed AI policy, an agent inventory with risk tiers, and a plan to ISO/IEC 42001 readiness
AI that runs in your region, on infrastructure you control, behind one governed gateway
The services, tools and rules that matter most in pharma and life sciences.
Start with a fixed-fee AI transformation review. We map your systems, data and teams against the six layers of Pegasus Agentic OS and name the first workflows to hand to agents. You keep the findings whether or not you work with us.