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. Legal representation service is covering, 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.
For any inquiry regarding our services, please contact Biomapas Business Development team.