About us
About us
Highly experienced regulatory experts will provide you and your contracted local CROs with competent, quick and cost-efficient sponsor representation services within the European Union, Switzerland and the United Kingdom.
Regulations (EU) 536/2014 for Clinical Drug Trials (CTR), Regulation (EU) 2017/745 for Medical Devices (MDR) and Regulation (EU) 2017/746, the In-Vitro-Diagnostic Medical Device Regulation (IVDR) require that a sponsor who is not based in the EU must appoint a representative if this sponsor wishes to conduct a clinical study in the EU.
Similarly, the Swiss Ordinances on Clinical Drug Trials and Clinical Investigations with Medical Devices also ask for a Swiss Representative if the sponsor is not established in Switzerland.
Since the Brexit, a local representative in the United Kingdom is also mandatory for conducting clinical studies, however, for the time being a representative in the EU is still accepted.