Deploy AI with inspection-ready governance
Executive advisory for biotech, pharma, and medtech teams deploying AI in regulated environments.
The problem
Why regulated AI stalls
AI ambition is easy. Regulated execution is hard. Most advisory stops at strategy. We focus on the execution architecture required for inspection-ready deployment.
AI governance is not a policy problem. Execution architecture determines whether AI is operationally ready and inspection-defensible.
Validation uncertainty
Operational control gaps
Vendor ambiguity
Internal disagreement
Audit defensibility concerns
Deployment paralysis
How it works
Three-step executive advisory framework
From assessment through architecture to ongoing advisory — built for inspection-ready deployment in regulated environments.
01
Assess
Evaluate governance posture, deployment risks, and operational readiness.
02
Architect
Define governance structure, validation approach, and execution controls.
03
Advise
Executive advisory to guide implementation and maintain defensibility.
Services
Advisory engagements
Primary engagement
90-Day AI Governance & Deployment Readiness Advisory
Structured executive advisory to move from governance intent to inspection-ready deployment — governance architecture, validation strategy, and execution controls aligned to your regulatory context.
Assessment
AI Governance Readiness Assessment
Structured evaluation of governance posture, validation gaps, and deployment readiness.
Session
Executive Advisory Session
Focused executive guidance on governance decisions, deployment risk, and regulatory readiness.
Architecture
AI Deployment Architecture & Validation Advisory
Hands-on advisory for deployment architecture, validation approach, and inspection-ready controls.
About
Built for environments where failure is not an option
Founder
Steve Thompson
Founder, INTEKNIQUE — advisor for AI governance in regulated life sciences
Former Senior Director at ValGenesis with leadership across regulated digital quality, validation, and GxP systems — extending CSV rigor into modern AI governance and inspection-ready deployment architecture.
INTEKNIQUE is boutique executive advisory — governance architecture, validation strategy, and inspection-readiness for organizations deploying AI in regulated environments. Not software sales. Not generic AI strategy.
Regulated digital quality leadership
GxP and computer systems validation across pharma, biotech, medtech, and CRO environments — including senior leadership at ValGenesis.
PDA Certified Computer Systems Auditor
Certified auditor with a practitioner’s view of inspection readiness and audit defensibility.
Computer scientist
B.S. in Computer Information Systems / Computer Science — technical depth applied to governance and validation architecture.
Author & industry voice
Published thought leadership and speaking on AI governance, GxP, and regulated deployment — including the AI for Life Sciences newsletter.
Resources
Executive briefs & checklists
Practical executive resources for regulated AI deployment.
AI Governance Readiness Checklist
A structured checklist for governance posture, validation gaps, and deployment readiness.
AI Deployment Decision Brief
Executive framing for deployment decisions, control design, and regulatory readiness.
90-Day Readiness Advisory Brief
Executive overview of the 90-day readiness engagement — scope, cadence, and outcomes for regulated AI deployment.
FAQ
Common questions
Do you build software?
No. INTEKNIQUE is executive advisory for AI governance, validation strategy, and inspection-ready deployment. We do not sell or implement a software platform as part of these engagements.
Who do you work with?
Biotech, pharma, and medtech leadership teams — including quality, regulatory, validation, digital, and executive sponsors preparing to deploy or scale AI in regulated environments.
What is the 90-day readiness plan?
A structured advisory engagement to assess governance posture, architect execution controls and validation approach, and advise leadership through inspection-ready deployment — typically over a 90-day cadence aligned to your organization.
How are you different from general AI consultancies?
We focus on regulated life sciences execution — governance architecture, validation strategy, and operational controls — not generic AI strategy or product roadmaps. Most firms stop at policy; we focus on inspection-ready deployment.
How do I start?
Schedule an advisory call below or submit the contact form. Steve will confirm fit, scope, and the right entry point — assessment, executive session, or the 90-day readiness engagement.
Schedule advisory
Start your 90-day readiness plan
Executive advisory with Steve Thompson — AI governance, deployment architecture, and regulatory readiness.
Schedule advisory call
Book a confidential introductory conversation with Steve Thompson, Founder.
Schedule via email
Prefer direct contact? steve@inteknique.com