CAPABILITIES

The firm advises medical-device, diagnostics, and life-science companies entering or expanding into the U.S. market — from corporate structuring and distribution arrangements to regulatory-adjacent commercial planning. We counsel manufacturers, importers, and distributors on the agreements and structures that govern their U.S. operations, including distribution and supply agreements, U.S. subsidiary formation, customs and import considerations, and commercial readiness for market launch. Leveraging over two decades of industry experience — including 17 years as General Counsel to companies operating at the intersection of clinical research, diagnostics, and regulated healthcare — Alcuin Law helps international and domestic companies build a credible, compliant, and commercially sound U.S. presence.

Recent work includes structuring U.S. market entry and distribution arrangements for a European orthopedic device manufacturer-importer, and advising a South Asian genetics technology company on its U.S. commercial and research operations.

 Alcuin Law supports international medical-technology and life-science businesses operating across jurisdictions, with particular depth in U.S.–partner arrangements involving research, data, and commercial collaboration. The firm advises on cross-border transactions, manufacturer-distributor relationships, global research collaborations and data-sharing agreements, and the practical realities of aligning U.S. legal requirements with a non-U.S. parent company's operations and expectations. With direct experience spanning U.S., Australian, Italian, and Indian corporate relationships, the firm bridges legal, scientific, and commercial expectations across markets to help clients move with confidence.

Recent work includes cross-border collaboration and contracting for CNS-focused biotech companies with U.S. and Australian operations, and structuring commercial relationships for a South Asian genetics technology company.

    Alcuin Law supports companies developing and commercializing diagnostics, cognitive and neuropsychological assessment tools, and other technologies used in clinical research and drug development. Drawing on nearly 20 years advising clinical and academic research programs — including CNS clinical trials for Alzheimer's disease and other neurodegenerative conditions, and early cancer detection through clinical laboratory diagnostics — the firm provides sophisticated counsel on scientific collaborations, licensing, research partnerships, and relationships with pharmaceutical sponsors and contract research organizations (CROs). Alcuin Law translates scientific and regulatory complexity into practical, defensible legal strategy for companies whose technology sits inside the clinical trial process itself.

Recent work includes advising U.S. and Australian biotech companies developing cognitive assessment data and technology for use in global CNS clinical trials. 

The firm delivers comprehensive counsel to organizations operating in highly regulated U.S. healthcare environments, including medical device companies, clinical and anatomic pathology laboratories, and management services organizations (MSOs). Drawing on direct experience as General Counsel and Compliance Officer for a medical device company with its own clinical laboratory, Alcuin Law assists with compliance architecture, reimbursement considerations, clinical-operations risk, medical-legal strategy, and day-to-day regulatory navigation. The firm provides pragmatic, industry-savvy solutions that support safe and sustainable growth.

Recent work includes compliance and operational counsel for a clinical laboratory focused on early cancer detection.

   Alcuin Law guides life-science, medical-technology, and health care companies through the full spectrum of corporate and commercial activity — from strategic contracting and governance to capital strategy and mergers and acquisitions. The firm delivers clear, practical, business-driven counsel rooted in over 20 years of industry experience including 17 years as General Counsel and Corporate Secretary. Alcuin Law structures and negotiates transactions that advance growth, protect value, and position clients for long-term success.

Recent work includes governance and commercial contracting support for CNS-focused biotech companies and a medical device manufacturer-importer.

  Alcuin Law helps clients build and maintain the privacy and data-use frameworks essential for today's healthcare and research environments. This includes HIPAA and state-specific obligations, clinical-research   data governance, vendor risk, and the complex requirements around handling, storing, and sharing sensitive health and research data — including cross-border data transfers between U.S. and international research partners. The firm pairs regulatory rigor with practical implementation to enable innovation without compromising trust.

Recent work includes data-governance guidance for cross-border CNS clinical trial data and cognitive assessment technologies.