For pharma, medtech and regulated mid-sized companies. Across Germany, based in Bernau near Berlin.
Strategy, architecture and delivery from one team. We combine AI and IT architecture with commercial and operational leadership and take digital initiatives in regulated industries from the first analysis into live operation.
Innovation in regulated industries does not take an appetite for risk.
It takes precision and clearly aligned solutions
that deliver today and still hold tomorrow.
The dioptra was an instrument for measuring and sighting, with which people explored the sky and aligned their buildings as far back as antiquity, long before the modern age. Kioptra carries that mindset into the AI era: measure, align, deliver.
Our name Ki-op-tra holds three disciplines: AI architecture, transformation and operational excellence. All of them point to the same place: your business result.
AI architecture, transformation, operational value creation and compliance work together. The markers show which disciplines apply.
End-to-end migration of a regulated pharmacy to Dynamics 365 Business Central as a single source of truth: integrated finance, inventory and batch management, e-commerce integration and event-driven automation on an AI-ready, EU-hosted data foundation. Industry- and data-protection-compliant, from P&L transparency to go-live.
Go-to-market and growth in regulated markets, from strategy to market success.
Efficiency, margin and cost control in regulated processes. Creating value without breaking compliance.
Digital production systems for cleanroom and regulated manufacturing, fully audit-ready documented.
Audit-ready Data Protection Impact Assessments as a repeatable procedure, including data processing in third countries and KDG.
AI solutions and agents we run ourselves, from Azure AI Foundry through local inference to knowledge-graph integration.
ISMS and operational security for regulated industries, from NIS2 and ISO 27001 to DORA, through to audit sign-off.
Most stop after the concept. We support all four stages, from process analysis to live operation, and stand behind the result.
We make initiatives audit-proof from day one, whether EU AI Act, NIS2, GDPR, GMP or DORA. In regulated industries, that’s not the last step but the first.
We operate AI ourselves, from Azure AI Foundry through local inference to knowledge-graph integration. Regulatory safety is part of the architecture, not an add-on.
We steer the delivery of complex, multi-stakeholder projects, from architecture to go-live, and make sure the system actually runs in the end.
We don’t stop at a clean system. From market entry, cost and margin we create measurable business value.
We are most at home in regulated pharma and healthcare environments, from ISMS and GMP production to the ERP migration of a large mail-order pharmacy. Experience beyond that: financial services, social economy and industry.
Over 15 years at the intersection of AI, IT architecture, security and regulation.
Diplom in business mathematics (TU Berlin), most recently Principal IT Architect at a leading German IT consultancy. Engagements include: security governance for an investment bank, internal AI concept designer on Azure OpenAI, enterprise architecture and cloud transformation for corporations with thousands of seats.
Over 10 years of commercial and operational leadership in highly regulated industries.
As COO & Managing Director of Cansativa GmbH, built the number 1 in a young, highly regulated pharma segment: growth to >€80M ARR (>100×), full P&L responsibility, GMP transformation and an international supply chain across 10+ countries; alongside fundraising (>€15M) and investor/board communication. Previously strategy consulting at BCG and VW Group Consulting.
Michael owns the technical and architectural side, Roland the commercial and operational one. That lets a small team cover what large companies need several departments for, without anyone having to translate between technology and business.
Yes. Our focus is regulated organisations, from mid-sized companies to corporate groups, above all in pharma, healthcare and medtech. Experience beyond that: financial services, social economy and industry.
With a conversation about your initiative. From there we work in four stages: regulatory framework, AI architecture, delivery and operational value creation, from the first analysis into live operation.
Regulation is our first step, not the last. We make initiatives audit-proof from day one, whether EU AI Act, NIS2, GDPR, GMP, Annex 11 or DORA.
Yes. We operate AI ourselves, from Azure AI Foundry with EU hosting to locally run models. For example, we draft data protection impact assessments with local AI so that data protection is preserved during the drafting itself.
From an AI initiative to ERP modernisation to operational scaling: tell us where it stalls. We sort out the rest in conversation.
info@kioptra.deKioptra · Bernau bei Berlin · Germany
