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EU Legal Representative

A trusted partner for conducting your clinical studies in Europe

Sponsors established outside the European Union who wish to conduct clinical studies in Europe must appoint a legal representative for their clinical studies to meet applicable regulatory requirements. Pharmaspecific supports pharmaceutical companies, biotechnology companies and medical device manufacturers by acting as their legal representative in Europe and facilitating their interactions with authorities and project stakeholders.

Drawing on our clinical research expertise and our knowledge of European regulations, we help international sponsors conduct their clinical studies in Europe in full compliance, while securing their regulatory, administrative and ethical obligations. Our EU legal representatives provide support tailored to sponsors’ needs and facilitate coordination with all stakeholders.

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Représentant légal d'étude clinique

We support in particular:

In vitro diagnostic device manufacturers

International biotechnology companies

Medical device manufacturers

Pharmaceutical companies

Our services include

Dedicated expertise for non-EU sponsors

We act as the legal representative for clinical studies on behalf of sponsors based outside the European Union, ensuring compliance with the regulatory requirements applicable to their clinical trials and clinical investigations conducted in Europe. Our legal representation in Europe facilitates communication with competent authorities and supports the coordination of regulatory procedures. Our EU legal representatives thus provide follow-up tailored to each sponsor's needs.

Regulatory and ethics support

Our teams track regulatory and administrative obligations, facilitate communication with competent authorities and support sponsors in their dealings with ethics committees. They also provide legal representation, in coordination with our representatives, to support sponsors in their clinical studies in Europe and meet applicable requirements.

In-depth command of European regulations

We support projects subject to the European regulations applicable to medicinal products, medical devices and in vitro diagnostic medical devices, including under the MDR and IVDR. Our legal representation gives sponsors support tailored to their clinical studies, backed by legal representatives familiar with the applicable regulatory requirements.

Regulatory representation for non-EU sponsors

Support for sponsors with no establishment in the European Union and management of the obligations associated with their legal representation.

Coordination of regulatory communications

Support for sponsors in their interactions with competent authorities and all project stakeholders to facilitate the regulatory follow-up of studies.

Ethics and administrative follow-up

Support with the preparation, submission and follow-up of the administrative and ethics procedures required to conduct clinical studies in Europe.

MDR / IVDR compliance

Support for medical device and in vitro diagnostic medical device manufacturers in meeting the European regulatory requirements applicable to their projects.

Support throughout the study

Ongoing follow-up of regulatory, administrative and documentation obligations to ensure project compliance through to close-out.

Ethics and administrative follow-up

Support with the preparation, submission and follow-up of the administrative and ethics procedures required to conduct clinical studies in Europe.

Why choose Pharmaspecific as your legal representative in Europe?

ENTRUST YOUR CLINICAL OPERATIONS TO AN EXPERIENCED CRO

By entrusting your legal representation to Pharmaspecific, you gain an experienced partner able to secure your regulatory obligations and support the roll-out of your clinical studies across Europe.

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Drapeaux de l’Union européenne devant un bâtiment institutionnel