Regulatory Affairs

With feasibility phase, regulatory submissions and hospital contracts negotiation are one of the most important part of the Study Start-up phase in a clinical trial.

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)

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