For validation, quality-tech and AI vendors
"Every deal now has a compliance workstream, and our customers' auditors ask questions our team can't answer." If you build software or AI for regulated quality, that moment decides the deal. Independent advisory helps you meet it prepared.
What it is not
A paid endorsement, a logo to sell, or a validated stamp in your marketing.
What it is
A candid, regulator-informed read, kept at arm's length from client work. That independence is what makes it worth having.
What this is, and what it is not
This is independent advisory: a candid read on whether your product fits how regulated quality teams actually work, where the compliance gaps are, and how to position it for senior pharma buyers. It draws on a regulator-side seat and years of enterprise delivery on the buyer side of the table.
It is never a paid endorsement. I do not sell logos, I do not appear in your marketing as a validated stamp, and I keep this lane at arm's length from my client engagements so neither side is compromised. That independence is the whole point; it is what makes the advice worth having.
What I do here
- I review the product and roadmap against current and emerging guidance, including the Annex 22 (AI) draft, and tell you plainly where it stands.
- I find the compliance gaps in a validation, eQMS or AI-in-GxP product before a buyer's auditor does, with a prioritised fix list you can act on.
- I shape your validation posture: the evidence pack, quality-system summary and test documentation your customers need to qualify you under CSA instead of re-testing you.
- I frame the go-to-market for senior quality and IT compliance buyers, grounded in the problems they actually raise.
- I pressure-test your claims so what the sales deck says survives a technical audience.
If your product carries AI, start with the rules your customers will be held to. My clause-level reading of the draft is in What the Annex 22 (AI) draft asks of you, and the AI Governance Stack is the structure your customers will use to govern what you sell them.
I have been the person your customers send to assess you
For years I ran vendor and supplier assessments for a global pharmaceutical client's system estate, deciding whose evidence could be trusted and whose had to be re-tested. I know which answers end that meeting well: a clear intended use, honest GAMP categorisation, test evidence a sponsor can qualify under CSA, and, for AI products, a straight story on training data, drift and human oversight. That is the posture we build, so the next assessment goes your way.
Questions vendors ask
What should our validation package include for pharma customers?
Enough for a sponsor to qualify your evidence under CSA instead of re-testing you: a quality-system summary, honest GAMP categorisation, documented testing of standard functionality, and your release and change practices. For AI products, add training-data lineage, performance evidence and the human-oversight model. A package built this way shortens every vendor assessment you face.
Does the draft EU GMP Annex 22 apply to software vendors?
It applies to your customers, which means it lands on you. Sponsors using AI in GMP will need documented intended use, data and model lifecycle controls, human oversight and monitoring, and they will source much of that evidence from their vendor. Products that can hand over that pack clear vendor assessment far faster.
Do you endorse or certify products?
No. I do not sell logos, appear in vendor marketing as a validated stamp, or take referral fees, and this lane stays at arm's length from my client engagements. What you get is a candid, private read on where the product stands and what to fix first. The independence is what makes it worth having.
Can you help us prepare for customer audits?
Yes. Sponsor audits follow a predictable script: quality system, testing practices, change control, data integrity, and for AI, model lifecycle and oversight. We rehearse those questions against your real evidence, close the gaps that matter most, and make sure the people in the room can answer without improvising.
Start a vendor-advisory conversation
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