Which industry is perfect for AI? Regulatory workflows in pharma and medtech
Carl-Axel Dahlin · 2026-05-28
Which industry is perfect for AI?
Legal (Legora) and software development (Lovable) are now obvious. But regulatory workflows in pharma and medtech get too little attention, in my view.
Tangled regulations, strict traceability requirements, authorities, notified bodies, and markets with different demands. Everything has to be documented, reviewed, and reported continuously.
The case: 18 months to 2.5 weeks
Here's an excellent case study from a US investment firm:
- A company had spent 18 months without managing to automate parts of its drug safety work.
- A new team delivered a working MVP in 2.5 weeks.
- The result: 90%+ efficiency gains, 65% cost savings, and case handling time went from 3+ hours to 10 minutes.
The key wasn't the model — it was the domain knowledge. They hired a physician (hi Tandem Health), built knowledge graphs specific to life sciences, and combined the models with expert feedback and traceability back to sources. A standard model landed around 60% accuracy on this type of patient safety task. That's nowhere near enough.
The interesting bit isn't that they "replaced Veeva"
The point is rather that even when Veeva, Oracle, or ArisGlobal are in place, much of the real cost still sits in Word, Excel, PowerPoint, handoffs, and people who read, interpret, extract, and review. That's where AI-native workflows can create disproportionate impact.
Where do the smaller companies stand?
I suspect the large pharma companies with AI muscle have already made some progress. But how are the small and mid-sized ones doing? And their regulatory consultants, CROs, and other service providers?
Processes that should yield good ROI
- Clinical Study Reports
- CTD Module 2 summaries
- CTD Module 3 CMC gap checks
- PSUR/PBRER
- Drug safety case intake
- Literature screening
- Clinical evaluation/CER
- PMS, PMCF, and PMPF
- MDR/IVDR PSUR
- SSCP
- GSPR evidence mapping
- Gap analysis of technical documentation ahead of notified body review
Phew. Just reading that list explains why the domain expert is central.
Get in touch
I'm curious but don't have the right contacts. Reach out if you work in RA/QA at a small or mid-sized medtech or IVD company, or as a regulatory consultant, and you see the potential of AI but don't have the bandwidth to put it into practice.