Legal Representative Clinical Trials
Your clinical gateway to Europe
Sponsors conducting clinical trials in the European Union without a registered European Economic Area (EEA) office must appoint an EEA-based legal representative per EU Clinical Trial Regulation. This requirement covers clinical trials involving medicinal products and medical devices.
Lumis acts as your legal representative in the EU, UK, and Switzerland. We handle legal proceedings within the EU/EEA, streamlining market authorization, saving you the costs associated with establishing your own subsidiaries. We also assist you with European Medicines Agency (EMA) recognition as a small and medium-sized enterprise (SME) and guide you through the process.
Since 2013, Lumis has supported biopharmaceutical, biosimilar, and medical device companies globally, backed by deep expertise in European legal requirements.
Our 3E Advantage: Expertise. Efficiency. Expedited.
-
Enter New Markets
Ease clinical trial and market authorization with regulatory compliance.
-
Obtain SME Status
Gain support in administration, regulation, and finances from EMA.
-
Reduce Expenses
Avoid the high costs involved in setting up your own subsidiaries.
Legal Representative Clinical Trials Services
As your trusted EU legal representative in Europe, the UK, and Switzerland, we advocate for you in EU/EEA legal proceedings, ensuring compliance with EU Clinical Trials Regulation 536/2014, previous EU Clinical Trial Directive (2001/20/EC), and Swiss Ordinance. We also assist non-European companies in securing SME status with the European Medicines Agency (EMA).
Legal representation in EU
A legal representative acts as the sponsor’s agent in any EU/EEA legal proceedings. Every clinical trial requires a legal representative.
Legal representation in UK
Clinical trial sponsors need to be registered in the UK or an approved country (including EU/EEA). If not, a legal representative is required. Lumis can act as your legal representative from our EU or UK offices.
Legal representation in Switzerland
For clinical trials in Switzerland, sponsors outside the country must appoint a Swiss-based representative per Article 2 (c) of the “Ordinance on clinical trials with therapeutic products.”
Legal representation to obtain SME Status
As your legal representative, we help secure small and mid-sized Enterprise (SME) status at the European Medicines Agency (EMA). Lumis holds SME status, allowing us to support you in accessing EMA benefits.
Contact us to find out more!
