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Need an EU Legal Representative
for Your EU/EEA Clinical Trial?

Comply with EU Clinical Trials Regulation (CTR) 536/2014 by appointing AAYT as your EU Legal Representative. Our budget-friendly service includes 14-day onboarding, a dashboard-driven workflow, and clear, centralized communication—no email threads, no surprises.

Appoint AAYT as Your EU Legal Rep

Meet EU clinical trial regulatory obligations faster—with less effort and no mistakes.
Manage everything in a secure audit-ready online dashboard, all supported by AAYT's EU regulatory experts.

24-Hour Responses

24-Hour Responses

Our EU regulatory consultants respond within 24 business hours. 

Budget-Friendly EU Rep Letter in 14 Days

Cost-Effective, 14 Day Setup

Avoid needless trial startup delays with the most budget-friendly service out there.
Regulatory Online Dashboard

Dashboard-First Workflow

Manage regulator communications, tasks, and more via a secure online portal.

 
Book Free Consultation

Key Questions About
EU Legal Representation

Non-EU clinical trial sponsors are legally required to appoint an EU Legal Representative before submitting an application under Regulation (EU) No 536/2014 for Clinical Trials (CTR) via the Clinical Trials Information System (CTIS).

Here are the essentials you need to know to proceed with confidence.

   Watch 2-Minute Video
Browse FAQs →

What is an EU Legal Rep?

An EU Legal Representative is a person or organization established in the European Union who acts on behalf of a non-EU sponsor under European Clinical Trial Regulation (CTR) 536/2014 Article 74. This representative is legally accountable for sponsor responsibilities within the EU and serves as the sponsor's point of contact for regulators.

Why do I need an EU Legal Rep?

If your company is based outside the EU and plans to conduct a clinical trial in one or more EU member states, you are legally required—under Article 74 of the EU Clinical Trials Regulation (CTR 536/2014)—to appoint an EU Legal Representative. Without one, your Clinical Trials Information System (CTIS) submission will be rejected.

How long does it take to appoint an EU Legal Rep?

Most sponsors get fully covered within 14 days. This includes document review, contract signing, and delivery of the signed EU Rep Letter—assuming prompt sponsor responses.

What Our Clients Are Saying

Clear, responsive, and fast. Our Phase I setup in Hungary would’ve been weeks behind without them.

Director of Clinical Operations

Biotech Startup (Boston, USA)

No fluff, just straight forward representation with zero hassle. Highly recommend for lean biotechs.

VP of R&D

Oncology Biotech (Tel Aviv, Israel)

We’re a first-time sponsor in the EU, and they walked us through every step like true partners. The onboarding was seamless.

COO

Rare Disease Biopharma (San Diego, USA)

Professional, transparent, and committed. Their fixed-fee model saved us both budget and internal debate.

CEO

Seed-Stage Biotech (Cambridge, UK)

They handled the rep setup, CTIS contact, and all email correspondence with regulators. Smooth as can be.

Head of Global Trials

Mid-Size Pharma (Singapore)

The trust they built in just one Zoom call was enough get internal approval to approve them as our rep. Worth every dollar.

General Counsel

Immunotherapy Firm (Los Angeles, USA)

7-Step Guide to Appointing
Your EU Legal Rep

Unsure how to navigate EU clinical trial legal requirements? Our 7-step guide simplifies compliance—from documentation to designation—so you can appoint your EU Legal Representative in days, not weeks, and keep your trial on track and on budget.

EU Legal Representative 7-Step Guide

Senior Regulatory Consultants Trial Sponsors Count On

With deep expertise in EU clinical trial regulations, we streamline onboarding and deliver ongoing regulatory support—serving as your official point of contact in the EU/EEA.

Launch with confidence and let AAYT’s experts keep your trial on schedule and compliant every step of the way.

Learn More About AAYT →
David Rozman

David Rozman

Senior Regulatory Consultant
Klara Novak

Klara Novak

Senior Regulatory Consultant
Lukas Baumann

Lukas Baumann

Senior Regulatory Consultant
Casper Meijer

Casper Meijer

Senior Regulatory Consultant

Book a Free Regulatory Strategy Session

We’ll help you assess your readiness to appoint an EU Legal Representative, answer your questions, and explore your eligibility for EU incentives for small and medium-sized businesses, promising new medicines, and treatment of rare diseases.

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Our senior regulatory affairs professionals reply within 24 hours—no pressure, no obligations.

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