Donlon Life Science Consulting Ltd

Donlon Life Science Consulting Ltd. delivers AI‑powered regulatory support for medical devices and combination products, blending cutting‑edge technology with seasoned human expertise. Founded and led by Lisa Donlon, a former Notified Body decision‑maker, the firm offers a security‑conscious workflow that accelerates documentation and submission timelines by up to 50 per cent while maintaining rigorous expert review of every output.

The consultancy’s core services are packaged in clear, fixed‑price tiers. A free “Compass Assessment” determines product classification and market eligibility, followed by a detailed “Regulatory Strategy” roadmap for a single jurisdiction. For companies aiming to expand globally, the “Global Navigator” package maps harmonised requirements across up to five key markets, providing a comprehensive playbook for international launch. In addition, Donlon Life Science offers a stand‑alone EMDN and reimbursement information app, built without AI and with no data sharing, to simplify everyday regulatory tasks.

By combining AI‑assisted efficiency with the assurance of professional oversight, Donlon Life Science Consulting gives life‑science organisations the certainty and traceability they need to bring innovative products to market confidently and on budget.