We provide representative services for our clients who want to access EU, UK and Switzerland and act as Applicant for Marketing Authorization Application (MAA) and liaise with EMA, MHRA and Swissmedic throughout the whole regulatory process from filing to approval. We also do act as Marketing Authorization Holder (MAH) for our clients ad-interim while supporting them to set up a legal entity in Europe.

As a certified Small and Medium-sized Enterprise (SME) from EMA, we specialize in navigating non-EU clients through the EMA submission process and benefit from financial and administrative incentives. By combining bespoke guidance with deep European expertise, we empower innovators outside the Europe to deliver vital therapies to European patients more swiftly and cost-effectively.

Our Swissmedic license is the cornerstone of our commitment to the highest standards of 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.