EU and FDA Regulatory
and Legal Expertise
Let our Pharmaceutical Legal Services team represent you. The team combines clinical and pharmaceutical industry knowledge with practical experience to provide you a comprehensive legal representative service. If your clinical trial includes requirements for the legal and technical processing of clinical trial research and drug development in Europe, we can offer a complete range of service options as part of a customized package. Your package will be designed to help you fully comply with European and U.S. requirements, including but not limited to:
- Legal Representation within the EU as defined by Directive 2001/20/EC Article 19
- Coordination with global and local authorities for Sponsor and investigator site inspections To ensure International Conference of Harmonisation (ICH), Good Clinical Practice (GCP) compliance in all aspects.
- Regular updates on relevant changes to EU legislation and/or local legislation.
- Liaison with the Ethics Committee and Competent Authority for clinical trial authorisation and amendment submissions Co-signing contracts between Sponsor and Investigator/Site (as required by some EU Authorities)
- Preparation of submissions for FDA and institutional review board (IBR) review
- Electronic submissions for sponsor and sites using cutting edge technology
- Dedicated teams for unique and customized requirements
- Translation services (including back-translation) of clinical trials applications
- Procurement of local patient insurance