Europa Advisory
EU regulatory and market entry advisory for life sciences technology companies navigating European expansion.
Europa Advisory helps life sciences technology companies navigate EU market entry — from regulatory pathway and entity formation to talent acquisition and compliance structure.
Kevin Shea is a partner in Europa Advisory, bringing deep experience in technology governance and validation to the firm’s EU expansion practice.
Focus Areas:
- Regulatory pathway assessment for EU market entry
- Entity structure and formation for European operations
- Talent strategy and compliance staffing
- NIS2 Directive readiness and compliance
- EU AI Act preparedness for regulated technology
- Cross-border compliance alignment (FDA/EMA harmonization)
Why Europa Advisory: Life sciences technology companies expanding into Europe face a different regulatory landscape — NIS2, EU AI Act, MDR, and IVDR create requirements that don’t map neatly to FDA frameworks. Europa Advisory bridges that gap with practical, experienced guidance rather than theoretical playbooks.
Particularly Relevant For:
- GxP software vendors targeting European pharma and biotech customers
- US-based life sciences companies establishing EU operations
- Technology companies preparing for NIS2 and EU AI Act compliance
- Organizations needing cross-border regulatory alignment