Legal Representation in Europe
The EU Clinical Trial Directive (2001/20/EC) requires every sponsor conducting a clinical trial in the European Union and not having a registered office within the territory of the European Economic Area (EEA) to work with a legal representative who is located in one of the EEA countries. This requirement applies to all clinical trials conducted with medicinal and/or pharmaceutical products as well as medical devices.
LUMIS International can be your legal representative in Europe to ensure that your company complies with the above requirements.
A legal representative acts as the agent of a sponsor in the event that legal proceedings are initiated and instituted within the EU/EEA.
Each and every clinical trial requires a legal representative.