In this field, currently under significant development from the normative point of view, Di Renzo Regulatory Affairs is able to offer technical and regulatory assistance for:

• Observational and interventional clinical trials
• Trials on new pharmaceutical products
• Preparation of the documentation to be submitted to the Competent Authority and to the Ethics Committees
• Data insertion into the OsSC system and into the National Register for the Observational Studies
• Translation of dossier and clinical protocols.