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NewAI that survives a GxP inspection: we help pharma, CROs and healthcare organisations put AI to work in pharmacovigilance, quality and regulatory operations — every solution delivered validation-ready, with audit trails and a human in the loop.
In regulated operations, highly qualified people spend most of their time on document handling rather than judgement. Our solutions move that work to AI — and keep the decisions, approvals and accountability with your team.
Hours of reading and re-typing per person per week become minutes of review — your experts do expert work.
Case volumes, document loads and audit demands grow every year. Pipelines absorb the growth; your team size doesn't have to.
Gaps surface when they're cheap to fix — not in the front room. Every answer comes with its evidence attached.
Every solution is scoped against a measurable baseline before you commit — here's the shape of the return, illustrated on typical industry workloads.
When AI does the reading, extraction and first drafts, each qualified person reviews multiples of what they could process manually. Example: a literature reviewer assesses an AI-flagged shortlist instead of screening every abstract — the same person covers several times the volume, at higher consistency.
Case intake that took 45–60 minutes becomes a few minutes of review. Training content that took days drafts in minutes. Inspection evidence that took a two-week scramble assembles in seconds. The lag between "document effective" and "organisation ready" collapses.
Case processing consumes 60–70% of a typical PV budget, and volumes grow ~10–15% yearly — automation absorbs that growth without matching headcount or outsourcing spend. Add the avoided costs: a single prevented finding, delayed launch or repeat inspection can exceed the price of the entire solution.
Figures are indicative of typical industry workloads. Your pilot establishes your actual baseline and measured return before any rollout decision.
From first roadmap to validated systems — start anywhere, each solution stands on its own.
Know where AI belongs in your organisation — and where it doesn't. We assess your operations, prioritise use cases by ROI and risk, and build a roadmap your inspectors won't argue with.
A chat assistant grounded exclusively in your own SOPs and quality documents — instant answers cited to the exact clause, with escalation to a named human when it shouldn't answer.
AI pipelines that read, extract and check your regulated documents — turning backlogs into structured, audit-ready data, with every output human-reviewed before it counts.
One searchable, AI-powered home for SOPs, deviations, CAPAs, inspection findings and regulatory correspondence — so institutional knowledge stops walking out the door.
Turns your own SOPs into training the moment they change — modules, change summaries and assessments generated from your documents, with role-based training matrices kept current automatically.
Be inspection-ready before the inspector is scheduled. Continuous readiness scans of your QMS, mock-inspection Q&A informed by published FDA 483s and warning letters, and evidence retrieval in seconds on the day.
The same lifecycle every time — because in a regulated environment, predictable process is the product.
We map your workflows, data and risk profile, and agree the use case with the clearest return.
A working system on your real documents within weeks — measured against baselines you define.
GAMP 5 validation package: requirements, risk assessment, test evidence and traceability.
Go-live with staff training, SOP updates, monitoring and ongoing performance review.
These aren't add-ons. They're the default state of everything we deliver.
Delivered with documentation aligned to GAMP 5 Second Edition, covering AI/ML-specific controls.
AI drafts, extracts and flags. Qualified people review and approve. No exceptions in GxP workflows.
Every AI action, review decision and change is logged and attributable throughout.
Patient and commercially sensitive data handled in your approved region. No training on your data.
Whitehall Training has spent decades teaching GCP, pharmacovigilance and GMP to the people who run regulated operations — including teams across the NHS, global pharma and CROs.
That means we build AI the way your inspectors expect your systems to be built: documented, reviewed, traceable. We speak MedDRA, Annex 11 and E6(R3) natively — no translation layer between your compliance team and your technology partner.
No. Most of our engagements start with quality, PV or regulatory leaders, not IT. We handle the technical build and validation; your team brings the process knowledge and the review. Where your IT department needs to be involved — hosting, integrations, security review — we work directly with them.
Yes, and we usually do. We can deliver end-to-end, act as the compliance layer on top of another vendor's technology, or advise your internal team while they build. The validation documentation and governance approach is ours regardless of who writes the code.
No — AI Solutions is open to any pharmaceutical, biotech, CRO, medical device or healthcare organisation. Existing training clients do get a head start, though: we already understand your teams and compliance context.
Every engagement starts under NDA. Your documents and data are processed in your approved hosting region, are never used to train AI models, and access mirrors your own permission structures. Data handling terms are agreed in writing before we see a single document.
Assessments and strategy work are fixed-fee, agreed up front. Implementation projects (assistants, pipelines, platforms) are scoped after a pilot, so you commit with measured results in hand — pilots run in weeks, not quarters. Platform solutions carry an annual licence and support agreement.
With a 30-minute conversation. If there's a fit, the usual first step is either a focused assessment (4–8 weeks) or a pilot of one solution in one department. We deliberately start small: in a regulated environment, a measured, validated first win beats a broad rollout every time.
Tell us where your teams lose the most time and we'll come back within one working day to arrange a free 30-minute consultation.
No sales sequence, no obligation — just a conversation with a consultant who knows your regulations.
