Healthcare and life sciences organizations operate where technology decisions carry consequences beyond the balance sheet. Every architecture choice has implications for patient safety, data integrity, and regulatory compliance across multiple jurisdictions. The margin for error is defined by regulators, not by project managers.
We bring direct operating experience in pharmaceutical M&A at global scale, GxP-validated infrastructure design, and software medical device go-to-market strategy. The difference between technology decisions that satisfy auditors and those that actually accelerate therapeutic development is the difference between compliance as a cost center and compliance as a competitive position.
Where We Focus
Pharmaceutical M&A Technology Integration — Application portfolio rationalization, data migration strategy, and regulatory-compliant platform consolidation during mergers and acquisitions. We led technology integration for one of the largest pharmaceutical mergers in history — a $62B transaction spanning 80+ countries with 300+ engineers.
Public Health Data Infrastructure — Architecture strategy and technology roadmaps for organizations managing privacy-preserving health data at scale. Multi-state research networks, bidirectional reporting systems, and data governance frameworks designed for sensitive population health data.
Software Medical Device Strategy — Go-to-market architecture, quality management system design, and regulatory submission support for SaMD products. FDA 21 CFR Part 11 and EU MDR compliance built into the architecture from day one — not retrofitted after development.
AI & Data in Regulated Environments — Responsible AI deployment strategy for organizations operating under GxP, HIPAA, and FDA oversight. Model governance frameworks that satisfy both regulators and data scientists without creating bureaucracy that stalls adoption.
