Legal Representative

Legal Representative

In accordance with the European Clinical Trials Directive, the Sponsor’s EU Legal Representative services 2001/20/EC are managed by our Legal Department, reporting directly to the CEO.

Whenever a Sponsor, who does not have a registered office in the EU, wishes to conduct a clinical study in the territory of the EU, the Sponsor is obliged to designate a legal representative who will act on their behalf with regards to the study. The legal representative acts as the first point of contact for regulatory authorities and third parties and supports the Sponsor with fulfilling legal obligations as applicable to the study.

We provide Legal Representative services only for the studies where it acts as the main contractor.

Key responsibilities:

  • Communicating where necessary with the relevant regulatory authorities, in connection with the appointment and fulfillment of the regulatory and other obligations.
  • Assisting the Sponsor in notifying and/or obtaining any required approvals from the relevant Competent Authorities and, in consultation with the Sponsor, preparing any other documents necessary or desirable to confirm or formalize such appointment as EU Legal Representative or informing third parties.
  • Preparing and signing applications, notifications and other documents in connection with the study (including letters of authority, applications for clinical trial authorizations and ethical approvals, applications for amendments thereto, and notifications of the termination or completion of clinical trials).

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Pharmacovigilance (PV)

A unique clinical research center in Europe with its own operating room