Legal Representative

The GCP-Service legal representative service was established in order to meet legal requirements of sponsor companies which do not have a subsidiary within the European Union and Switzerland, for the purpose of performing clinical research projects in this region.

Such a “legal representative” for clinical drug trials or “authorized representative” for medical device trials fulfills the obligation that the sponsor companies must be established or represented in the European Union.

We can represent you in all member states of the European Union for your drug and medical device trials to enable submission of your regulatory applications to the European authorities and ethics committees.

We offer support for you and your contracted local CROs who might not be able or experienced to provide required representation services.

A group of highly experienced regulatory experts at GCP-Service will provide you with competent, quick and cost-efficient representation services.

 

Legal representation services are based upon:

  The Clinical Trials Directive 2001/20/EC requires that for all clinical studies with pharmaceuticals in the European Union a sponsor or a legal representative of the sponsor must be legally registered within the European Economic Area.

  The Medical Device Directive 93/42 EEC requires that for clinical studies with medical devices a manufacturer or an authorized representative is established in the European Union.

 

Our Services include:

-We operate in more than 30 countries

-We ensure ICH E6 and/or ISO14155 compliance

-We prepare your sites prior to inspections by national and international authorities

-We are flexible and extremly cost-effective

-We provide oversight to foreign sponsors by using electronic Trial Master Files (eTMF) according to the EMA reflection paper on TMF