AI GxP validation for regulated life sciences
WhatsApp +31 647553735connect@cybroscape.com
AI Strategy · Governance · GenAI · AI CoE · Agentic AI

AI Transformation

AI transformation designed for regulated life sciences: strategy, governance, adoption, agentic systems and AI Centres of Excellence — validated where it needs to be, fast where it can be.

Quick chat on WhatsAppHuman review at every gatePart 11 readyISO 9001 & 27001 certified
AI strategy life sciencesAI governanceGenAI adoptionAI Center of ExcellenceAI CoEAI validation servicesintelligent automationagentic AI systems
FDAEMAMHRAPMDACDSCOGAMP 5ICH Q921 CFR Part 11
In short

AI transformation for regulated life sciences covers strategy, governance, adoption, agentic systems and AI Centres of Excellence. The usual blocker is not technical capability but assurance posture: teams have working pilots they cannot promote to production because nobody has defined what the use case must demonstrate before it is allowed to touch a regulated process.

7 disciplines

Every ai transformation discipline we deliver

Each one has its own page with scope, deliverables and timelines.

AI Strategy

Portfolio prioritisation, build/buy, TCO, risk, ROI — and a phased plan that does not stall at pilot.

Learn more about AI StrategyAI Governance

Policies, model registry, use-case intake, risk classification, HITL policy, red-teaming and drift — designed for regulated environments.

Learn more about AI GovernanceAI Validation

Same as our validation-side AI validation service — surfaced here for AI-transformation buyers.

Learn more about AI ValidationGenAI Adoption

Use-case shortlisting, prompt libraries, evaluation harnesses, HITL patterns, and change management — GenAI that ships and stays shipped.

Learn more about GenAI AdoptionAI Centre of Excellence (AI CoE)

Charter, operating model, staffing, funding, intake, delivery, governance — and a demand pipeline that keeps it in business.

Learn more about AI Centre of Excellence (AI CoE)Intelligent Automation

Process discovery, automation architecture, agentic orchestration and lifecycle management — for regulated back-office and lab workflows.

Learn more about Intelligent AutomationAgentic AI Systems

Multi-agent design, tool use, memory, evaluation and HITL gates — engineered for regulated processes where mistakes are expensive.

Learn more about Agentic AI Systems
1Bounded intended useWhat the model does, and what it must not be used for
2A frozen evaluation setHeld-out data, version-controlled, agreed before testing
3A release gate that holdsAcceptance criteria set in advance, results recorded
4A person decides what mattersConsequential calls are made and signed by a named person
5Drift monitoring in productionInputs, outputs and overrides watched, with authority to suspend
6A fallback that actually runsThe process continues with the AI switched off
Annex 22 · consultation draft
The six parts of validating an AI system for GxP use. They map onto what the EU’s draft Annex 22 asks for. Annex 22 is still a consultation draft, not yet in force.
Case study · Pharmaceuticals

GenAI adoption programme for a Top-20 pharma

A Top-20 pharma had dozens of GenAI pilots that had multiplied without governance.

Read the case study
3/3Flagship use-cases in production
6 moTo operating CoE
SharedPrompt and evaluation library across teams
100%New use-cases assurance-classified

Tell us what you need from ai transformation.

A AI lead reviews your situation and proposes the smallest scope that does the job properly.

  • We reply within one business day
  • We look at your situation before we quote
  • You get a clear plan and scope
Chat on WhatsApp

Talk to a AI lead

Four fields. The right specialist replies within one business day.

Your details stay private. We never share them.