LEGAL REPRESENTATION

LEGAL REPRESENTATION

Key Services

EU Legal Representative for Drug Clinical Trials (EU CTR 536/2014)

Ensuring CTR compliance, GCP standards, and acting as EU sponsor contact for drug clinical trials.

EU Legal Representative for Medical Device Clinical Investigations (EU MDR 2017/745)

Providing MDR compliance, ISO 14155 alignment, and regulatory liaison for medical device clinical investigations in Europe.

Comprehensive EU Clinical Trial Compliance & Representation

Full-scope representation covering CTR and MDR, ensuring compliance and fluid communications between sponsor and regulatory bodies across Europe.

EU Legal Representative for Drug Clinical Trials (EU CTR 536/2014)

Ensuring CTR compliance, GCP standards, and acting as EU sponsor contact for drug clinical trials.

EU Legal Representative for Medical Device Clinical Investigations (EU MDR 2017/745)

Providing MDR compliance, ISO 14155 alignment, and regulatory liaison for medical device clinical investigations in Europe.

Comprehensive EU Clinical Trial Compliance & Representation

Full-scope representation covering CTR and MDR, ensuring compliance and fluid communications between sponsor and regulatory bodies across Europe.

Unlock EU Market Access for Your Clinical Trials

Appointing a trusted EU Legal Representative is essential for non-EU sponsors starting drug or medical device studies in Europe. At GCP-Service, we go beyond the “post box” role, ensuring compliance with EU CTR and MDR, streamlining regulatory submissions, and providing expert guidance for smooth trial execution. Partner with us for reliable representation and added value in every step of your clinical research journey.

Expertise

Trusted EU Legal Representation Across All Member States

We support sponsors across all EU member states and the UK. Our experts ensure compliance and smooth clinical trial execution from start to finish.

Regulatory Expertise Tailored to Global Sponsors

We deliver cost-efficient EU representation for drug and device studies. With 12 completed studies and repeated business from global sponsors, we are a proven long-term partner for successful trials in Europe.

End-to-End Oversight and Compliance Management

Beyond representation, our team ensures ongoing compliance with EU CTR, MDR, and GDPR standards, supporting you in keeping your studies inspection-ready.

MEET OUR
TEAM

Smooth, compliant, and reliable representation starts here.

Contact us for expert guidance!

MEET OUR
TEAM

Smooth, compliant, and reliable representation starts here.

Contact us for expert guidance!