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EUROPEAN LEGAL REPRESENTATIVE SERVICE

FOR SPONSORS WITHOUT A REGISTERED OFFICE IN EU/EEA

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EUROPEAN LEGAL REPRESENTATIVE SERVICE

COMPETENCE | FLEXIBILITY | COST-EFFICIENT

According to Art. 19 of the EU directive 2001/20/EC a Sponsor wishing to conduct a clinical trial in the European Union must either have a registered office within the European Economic Area (EEA) or work with a legal representative with an established office within the EEA community. With an office in Milano (Italy) Twiga Europe is specialized in complying with the Clinical Trial regulations released by the EMA, and therefore is an ideal provider to serve as your Legal Representative in Europe. The EU legal representative does not endorse the sponsor’s responsibilities of initiating, managing and financing the clinical trial but performs the tasks listed below.

Our legal representative service includes:

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Help sponsors understand the regulatory requirements in Europe

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Put together a customized solution to ensure compliance in European countries

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Prepare clinical trial authorizations and amendment submissions by working with the relevant Ethics Committees and National Competent Authorities

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Stay up-to-date on and communicate EU legal requirements

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Assurance of smooth and timely communication with the professional bodies

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Assist in coordinating site inspections to comply with the International Conference of Harmonization (ICH) and Good Clinical Practice (GCP)

Our team consists of professionals very expert in GCPs, Clinical Trial Applications, Clinical Trial Regulation (CTR), GDPR, Medical Monitoring & Pharmaco Vigilance, European and National regulatory requirements. We reduce time and resources waste.

A special power of attorney appointing the legal representative must be signed by the sponsor and must be included in each initial application to a Competent Authority or Ethics Committee regarding the protocol.

We can represent you in all member states of the European Union for your drug and medical devices trials, to enable the submission of your project to the European Competent Authorities and Ethics Committees.

Contact us now

Twiga Europe, through an highly qualified and acknowledged team of professionals an partners, delivers an uncommon service efficiency and quality. Please do not hesitate to contact us at the addresses below.