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AI Consulting & Strategy — a validated roadmap for AI in your organisation
AI Consulting & Strategy is the front door to everything we do. In a fixed-fee engagement, we assess your PV, quality and regulatory operations, prioritise AI use cases by return and risk, and hand you a roadmap and governance pack your inspectors won't argue with.
Invest where AI pays back — and skip where it won't
Most AI waste in this industry isn't failed technology — it's effort spent on the wrong use case, or a pilot that dies at validation. A fixed-fee assessment makes those mistakes before you do, on paper, cheaply.
The working day today
- Vendor pitches arrive weekly, none scored through a compliance lens
- Pilots get built enthusiastically, then die at validation or IT review
- EU AI Act obligations are somewhere between unclear and ignored
- The board wants an AI strategy; the organisation has scattered experiments
- Nobody can say which use case should be first — so nothing is
With this solution
- Every candidate use case scored on return, risk, data readiness and validation burden
- Validation strategy is designed in from day one — pilots are built to survive it
- AI Act classification, gap analysis and an Article 4 literacy plan, done
- A gated roadmap with owners and dates — investment follows evidence
- An explicit priority list, and an equally explicit "not now" list
What that means in productivity, time and money
The engagement itself is fixed-fee with defined deliverables — the return shows up in what you build, and what you avoid building.
Instead of scattered experiments, your teams work the two or three use cases with the strongest scored return — with governance and validation planned, so the work ships instead of stalling.
Organisations routinely spend quarters debating AI direction. A fixed-scope assessment compresses that drift into a dated, gated plan your leadership can approve in one meeting — and your regulators can recognise.
An AI pilot that dies at validation typically burns months of effort and six-figure spend. Fixed-fee assessment pricing, gated investment and an honest "don't build this" list mean you spend on evidence, not enthusiasm.
Figures are indicative of typical industry workloads. Your pilot establishes your actual baseline and measured return before any rollout decision.
Deliverables, not decks
Every engagement ends with documents your organisation can act on — and show an inspector.
AI opportunity assessment
A structured review of your PV, quality, regulatory and clinical operations: where time goes, where errors happen, and where AI credibly helps.
Use-case prioritisation
Every candidate scored on return, risk, data readiness and validation burden — including the honest "don't build this" list.
Implementation roadmap
A phased plan with each stage gated on measured results, so investment follows evidence rather than enthusiasm.
Governance & policy pack
Organisational AI policy, an SOP for AI use in GxP processes, and the oversight structure that makes both real.
EU AI Act readiness
Classification of your intended uses, gap analysis against obligations, and an Article 4 AI literacy plan for your workforce.
Build-vs-buy guidance
Vendor-neutral evaluation criteria and, where buying makes sense, support assessing candidates — including scrutiny of our own solutions.
Governance pack includes
Board-ready documents your organisation can adopt — and show an inspector — not slideware that sits unused.
Four leaders, four versions of the same question
"Everyone's pitching AI. What would actually survive our next inspection?"
You need the compliance lens first: which uses are defensible under GAMP 5 and Annex 11, what the validation burden really is, and where human accountability must sit. That's the assessment's spine.
"Case volumes grow 15% a year. Headcount doesn't."
PV has the clearest AI economics in the industry — and the most sensitive data. We quantify the case-processing and literature-screening opportunity on your actual volumes before you commit to anything.
"We can build it. Should we?"
Capable internal teams often lack the GxP validation experience that makes AI deployable in regulated processes. We slot in as the compliance layer: requirements, risk frameworks and validation strategy for what your team builds.
"The board wants an AI strategy by next quarter."
Strategy under deadline pressure usually produces slideware. A fixed-scope engagement produces the opposite: prioritised investments, governance the regulator recognises, and a literacy plan that satisfies the EU AI Act.
A fixed 4–8 week engagement
Scoped up front, priced up front, delivered on a date.
Discover · wks 1–2
Interviews with process owners, systems inventory, data readiness review, volumes and pain-point baselining.
Assess · wks 3–5
Use cases identified and scored on return, risk, data readiness and validation burden — with your teams, not at them.
Prioritise · wk 6
Workshop with your leadership: agree the shortlist, the sequence, and the explicit not-now list.
Roadmap & handover · wks 7–8
Final roadmap, governance pack and board presentation delivered — yours to execute with us or without us.
Advice from people who teach the regulations
Our consultants come from the same bench as our training faculty — GCP, GVP, GMP and computerised systems compliance.
GxP-native
We speak MedDRA, Annex 11 and E6(R3) natively — no translation layer between your compliance team and your AI advisor.
Vendor-neutral
The assessment scores every option — including recommending other vendors or internal builds where they fit better than our own solutions.
Regulation-current
EU AI Act, FDA's evolving AI guidance, EMA reflection papers, GAMP 5 Second Edition — tracked continuously, because it moves quarterly.
Strategy to system
If you choose to build with us, the same team that wrote the roadmap delivers it — assessment assumptions survive contact with implementation.
Questions leaders ask before engaging
Are you really vendor-neutral if you also sell AI solutions?
Fair challenge. The assessment methodology scores use cases and delivery options on criteria agreed with you up front, and the report shows the scoring — so a recommendation for our own solution has to survive the same scrutiny as anyone else's. Several deliverables (governance pack, AI Act readiness, literacy plan) are vendor-independent by nature. And the roadmap is yours: plenty of clients execute it with internal teams or other vendors.
Do we need our data organised before starting?
No — data readiness is part of what we assess, not a prerequisite. Knowing that your legacy archive is a mess is itself a finding that shapes the roadmap. You need nothing prepared beyond access to the right people for interviews.
We've already started AI work with another vendor. Is this still useful?
Often more so. A common engagement is a mid-flight review: assessing an in-progress AI project against validation and AI Act requirements before it reaches production. We work alongside your existing vendor as the compliance layer rather than replacing them.
What does it cost?
Engagements are fixed-fee, agreed after a free scoping call, and scale with the number of departments and sites in scope. A single-function assessment (e.g. PV only) sits at the lower end; a multi-site organisational strategy at the upper. You'll have the exact figure in writing before anything begins — no day-rate drift.
What happens after the 8 weeks?
Three common paths: you execute the roadmap internally (we hand over and step back), you engage us for the first pilot from the priority list, or you keep a light advisory retainer for governance reviews and regulatory updates. The roadmap is written to work in all three cases.
Every solution on this site started with this conversation.
A free 30-minute scoping call: tell us your operations and your constraints, and we'll tell you honestly whether an assessment would pay for itself — and what it would cost.
Book a scoping callFree · no obligation · fixed fee quoted in writing before you commit