At Luminance Health we foster meaningful growth in Life Science.
With our cross-functional consulting services, we support pharma, biotech and medtech organizations to achieve sustainable success and continuously uphold industry standards while navigating dynamic and international regulatory landscapes across the lifecycle of medicinal products, devices, IVDs and combination products.
We provide personalized, expert-led, cross-functional support in development, regulatory affairs, quality assurance, pharmacovigilance, medical and regulatory communications, market access, public affairs, healthcare compliance, project management, establishing and scaling-up companies.
With our offices in Switzerland and Austria as well as our strategic partners across the globe, we support access to markets for our clients globally.
Swissmedic License: GxP Quality Management System
Our Swissmedic licence is the cornerstone of our commitment to the highest standards of Good Practice (GxP). Supported by a fully implemented Quality Management System that meets Swissmedic’s requirements, we ensure every stage is rigorously documented, controlled and subject to continuous review.
SME Status: Enabling EMA Access for Non-EU Innovators
As a certified Small and Medium-sized Enterprise (SME) under European Medicines Agency criteria, we specialise in navigating non-EU clients through the EMA submission process. By combining bespoke guidance with deep EMA expertise, we empower innovators outside the EU to deliver vital therapies to European patients more swiftly and cost-effectively.