After the Ph.D. in Biotechnologies and different experiences in the university, I joined PTM and became Managing Consultant. My activities are mainly focused the pharmaceutical and medical device/combination products world: I also lead some activities for food companies with particular attention to quality and compliance of packaging materials. My support for pharmaceutical/medical companies is focused to the implementation of the Quality by Design (QbD) and Quality Risk Management (QRM) approaches from the early stages of development up to the registration of the product including the validation of the product and its process. For the product I follow I often support the preparation of regulatory documents (e.g. briefing packages, technical dossier, Module 3 of the CTD).