AI Strategy & Governance for Regulated Life Sciences

Your AI works. Can you prove it?

We help pharma and biotech companies deploy AI in drug development workflows — with the validation, documentation, and governance frameworks that regulators expect and auditors demand.

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Strategy

    

      AI strategy that starts with your science,

      not the other way around.
    

    

      Most AI strategies in life sciences begin with a vendor demo and end with shelfware. I help regulated companies build an AI roadmap grounded in scientific workflows, compliance reality, and measurable value — so every investment is defensible, not decorative.
    


    

      

        
The Problem

        

          
AI pilots that never scale

          
Teams launch experiments without aligning to regulatory requirements, and then wonder why QA shuts them down before production.

        

        

          
Vendor-driven decisions

          
Platform purchases based on demos instead of fit-for-purpose assessment. Expensive tools sit idle because no one validated the use case first.

        

        

          
Cross-functional stalemates

          
IT speaks one language, QA speaks another, and R&D speaks a third. Without a translator, AI adoption stalls at the org chart.

        

      

      

        
What I Do

        

          
Map AI to your actual workflows

          
I audit your R&D, CMC, and Quality processes to identify where AI creates real value — not where a vendor says it should.

        

        

          
Build a compliance-first roadmap

          
Every recommendation comes with a validation path. CSA, Part 11, and your QMS are built into the strategy from day one — not bolted on after.

        

        

          
Align your stakeholders

          
I bridge the gap between digital, quality, and science teams so your AI strategy has organizational buy-in — not just a slide deck.

        

      

    


    

      
How We Work Together

      

        

          
01

          
AI Readiness Assessment

          
A focused evaluation of your current tools, workflows, and compliance posture — with a clear picture of where AI fits and where it doesn't.

        

        

          
02

          
Use Case Prioritization

          
I rank AI opportunities by regulatory feasibility, workflow impact, and time-to-value — so you invest in what moves the needle first.

        

        

          
03

          
Validated AI Roadmap

          
A 30-60-90 day plan with defined use cases, validation milestones, resource requirements, and audit-ready documentation strategy.

        

      

    


    

      
Built For

      

        Biotech & Pharma Leadership
        QA / Validation
        Digital & IT
        R&D Informatics
        Clinical & Medical Affairs
        Pharmacovigilance
      

    


    

      

        Not sure where AI fits in your organization?

        Let's figure it out together.
      

      Book a Strategy Call