Life sciences and regulated software
Software for regulated work. Validated, auditable and moving to SaaS.
In regulated industries a change is only done when it can be shown to an auditor. I lead platform development and SaaS transitions for life sciences and compliance software, and bring in AI under the same discipline.
- Life sciences platforms
- Regulatory software SaaS move
- Validation and audit
The challenge
Nothing ships until it is validated. AI included.
You want AI in documentation, submissions and quality work, where every output has to be validated. Without evals and an audit trail, AI stays a pilot that quality assurance will not sign off.
How I help
Pick where to start. Six ways to work together in life sciences and regulated software.
Three outcomes at a fixed price, and three roles monthly or on demand. Most clients start with one and add a second.
SaaS & AI product launch
Agentic frame included
A regulated SaaS product launched for its first customers, with audit history and roles from day one.
AI agent evaluation
Right problem, solved right
AI outputs in documentation and quality work validated against your standard before use.
Enterprise AI agents
Every decision has an owner
Document and quality processes run by agents, with a qualified person signing off.
Fractional CTO
Technical direction you can trust
Architecture, validation and the development team for regulated software.
Product Lead
What to build, and why
Regulatory and user needs turned into specs that hold up in validation.
AI Architect
AI that holds in production
AI with evals, permissions and logs designed for audits.
Who you work with
Fractional CTO and product lead, Vienna
I lead platform development and SaaS transitions for life sciences and compliance software.
Delivered within my work as Fractional CTO, Product Lead or AI Architect.
“Kristian is certainly one of the top picks in his field.”
Product, technology and AI in one person. So the decisions never contradict each other.
- 25 years
- In software architecture and product, in Europe and North America.
- 50+
- Product launches across startups and enterprises.
- 5.0★★★★★
- Upwork rating, Top Rated Plus, more than $500K earned.
Questions
FAQ
Can you lead a move from on-premise to SaaS?
Yes. I set up and lead the transition across sales, product, business and technical teams.
How does AI fit validated processes?
Every AI output is checked against a written standard, logged, and signed off by a qualified person before it is used.
Do you work inside enterprise IT?
Yes. I work in your systems and your quality process, and every decision is written down.
Get in touch
Start with a call.
We go through your product, your team and where AI belongs in your work. You leave with a view on the right first step.
Services: SaaS & AI product launchEnterprise AI agentsAI agent evaluationFractional CTOProduct LeadAI Architect