From the strategy to the operativity
Thanks to our experts, we offer strategic consulting services to companies operating in the medical field, in the Regulatory Activities and Quality field, on site and remotely.
Step by step by your side
Thema experts follow complex regulatory changes and they guide you in the transformations necessary to operate successfully in the Medical Devices and in vitro diagnostic Medical Devices.
- Definition of the regulatory marketing strategy.
- Consultancy on national and international regulation.
- Feasibility analysis for placing on the market in the target Country.
- Quality Technical Agreement (QTA) draft.
- Regulatory Intelligence.
Strategic Regulatory Consulting
Italian and European Ministerial Registrations
International Registrations outside the EU