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     Regulatory Affairs Strategy

          * Scientific and medical project strategy and accountability for designing the clinical studies to meet
             guidelines, requirements and objectives

          * Study-Start-Up (SSU) activities - ethical (EC) and regulatory (CA) submissions

          * Organization of Meetings and Contacts with European Regulatory Authorities

          * Review and finalization of essential documents required for site initiation, including study protocol

          * Provide medical and scientific input to core documents for the project (e.g., target product profile (TPP),
             protocols, submissions)


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