European Union Legal Representative services

As part of our full suite of clinical trials solutions, Cromos Pharma provides a European Union Legal Representative service to Sponsors who do not have a registered office in the EU/EEA

Why do I need this service?

If you are a sponsor seeking to conduct clinical trials in the European Union and do not have a registered office in the European Economic Area you are required to work with a Legal Representative registered in an EEA country, according to the European Union Clinical Trial Directive 2001/20/EC.

What does the Legal Representative do?

The Legal Representative acts as the sponsor’s agent in any legal proceedings initiated in the EU / EEA regarding clinical trials and ensures that the sponsor complies with the EU Clinical Trials Directive (2001/20 / EC). This applies to all clinical trials of drugs and medical devices.
Our EU Legal Representative service operates from our EU headquarters in Dublin, Ireland.

What we offer

A clinical gateway to Europe
Through our clinical development and Legal Representative services, we offer access to the European market.
A team that represents your interests
Our expert team represents you in relation to clinical trials before the regulatory authorities and other national, local or EU government and professional bodies with jurisdiction over the clinical trial.
Save costs and time
Our representative service saves you costs and resources by eliminating the requirement to establish a registered office in the EU/EEA.
You benefit from our expertise and experience
We have in-depth knowledge of the legal and national requirements in EU member states and EEA.

Cromos Pharma has over 18 years of experience in managing all aspects of clinical trials across a range of therapeutic areas. With operations in the US, Central and Eastern Europe we combine global expertise with profound local market knowledge to deliver end to end solutions supporting our pharma and biotech clients.