Regulatory submissions

Depending on the nature of a clinical study, approval from national Competent Authorities (CA), country regional authorities and one or more accredited Medical Ethical Research Committees (aMREC) is required. In close collaboration the submission dossiers for both the CA and aMREC will be prepared in accordance with international and local regulations. Siron will centrally manage the entire process efficiently in anticipation of receiving all applicable approvals.

For our US customers Siron is organized to fulfill the role of EU legal representative and EU data controller representative.