ExperTrials’ Head of Regulatory Affairs coordinates all country Clinical Research Consultants (CRC) who will be responsible for Regulatory activities in their respective country. As our CRCs are locals, you can count/rely on their awareness of the applicable regulations in each region/country.
Our CRCs have strong experience in regulatory affairs activities related to clinical trial applications and marketing authorisation procedures for both drugs and Medical Devices.
As each project is unique, Expertrials will provide a tailor-made and flexible package to deliver a specific service to adapt our client’s needs. Our team will undertake your whole regulatory requirements or to perform more specific tasks.
Examples of our Regulatory Affairs services :
Consultation on legislation and country-specific requirements
Support with regulatory strategies
Preparing and filing clinical trial applications
Multi-country submissions and effective follow-up to Competent Authorities and Ethic Committees
Substantial and non-substantial amendments throughout the clinical trials
Management of clinical trial agreements with sites (hospital contracts)