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Legal and GDPR Representation

According to the EU Directive for Clinical Trials, Sponsors who do not have a legal residence in European Union or Switzerland must have a legal representative in order to conduct clinical trials.

Biomapas’ Legal and GDPR representation services cover, whilst not limited to:

  • Interaction with the Competent Authorities and the Ethics Committees as the legal representative of the Sponsor;
  • Assurance of smooth and timely communication with the professional bodies;
  • Collection and storage of all Clinical Trial related information and documentation;
  • Implementation of the Competent Authority decisions related to the Clinical Trial.