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.

Legal Representative Clinical Trials Europe

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

Legal representation in UK

Legal representation in Switzerland

Legal representation to obtain SME Status

Contact us to find out more!

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Andrés Aguilar Caro