US Life Sciences Tech Company Expanding into Europe
A US-based GxP software vendor or service provider navigating EU regulatory requirements for the first time.
The Situation
You’re a US-based life sciences technology company — SaaS, AI/ML tools, or clinical platforms — with European customers asking you to operate in the EU. Or you’ve decided to establish an EU presence to compete for European pharma and biotech accounts. Either way, you’re facing a regulatory landscape that doesn’t map neatly to what you know from FDA.
What Goes Wrong Without Help
- Entity structure is chosen for tax efficiency without considering regulatory implications
- NIS2 Directive requirements are discovered after go-live, creating urgent and expensive remediation
- EU AI Act classification and compliance obligations are underestimated — especially for clinical AI tools
- Talent strategy doesn’t account for EU labor law, works councils, or local compliance staffing needs
- ISO and GxP compliance approaches built for the US market don’t satisfy EU customer expectations
- Data residency, GDPR, and cross-border transfer requirements create architectural surprises
What Driftpin Does
Through Europa Advisory — where Kevin Shea is a partner — we provide:
- Regulatory pathway assessment — map EU requirements (NIS2, EU AI Act, MDR/IVDR) to your product and business model
- Entity formation guidance — structure that supports both regulatory and commercial objectives
- Compliance gap analysis — identify where your current FDA-aligned approach needs adaptation for EU expectations
- NIS2 readiness — cybersecurity risk management, incident reporting, and supply chain security obligations
- EU AI Act preparedness — risk classification, transparency requirements, and conformity assessment planning
- Talent and compliance strategy — staffing, local expertise, and operational compliance structure
Typical Engagement
Duration: 3-6 months for assessment and strategy; ongoing advisory as needed
Outcome: A clear, actionable EU market entry plan that accounts for regulatory, operational, and talent requirements — not a theoretical framework that falls apart at implementation.