As required by Article 19 of the EU Clinical Trials Directive (Directive 2001/20/EC), if the Sponsor does not have an office or registered address in the EU and they wish to perform clinical trials in the EU they must have a legal representative who is established within the European Union.
This provision is mandatory and without a Legal Representative the clinical trial will not be approved by the Regulatory or Ethics authorities.
The Legal Representative may be an individual person or a representative of a corporate entity, should be willing to act as the agent of the sponsor in the event of any legal proceedings instituted in the European Economic Area (EEA), e.g. for service of legal documents, and should be established and contactable at an address in the EEA;
We have 5-year expertise in representing non-EU Sponsors (from U.S., Canada, Israel) and our legal representative services will be provided to you by experienced staff, trained in clinical trial processes and legislation, and in the EU regulatory environment.