The Regulatory Science Unit provides support in defining the appropriate and applicable regulatory strategies for the implementation of a clinical research project and in the process of the various phases of the development of drugs, vaccines and medical devices.

Coordinating with the Clinical Trial Quality Team Service (CTQT) and with the Start Up Service, it intervenes to provide specific support for structuring the clinical trials related to OPBG-CSF so that they are usable from an ethical/regulatory point of view, contributing to the review and validation of the ethical/regulatory documentation of the specific study.

It also provides researchers, where necessary, with specific ethical/regulatory advice in the context of specific research projects (Horizion Europe, IMI2, IHI, Ministry of Health, AIFA, etc).