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.

Some services:

• Definition of the regulatory marketing strategy.
• HelpDesk – Questions&Answers on online platform.
• Consultancy on national and international regulation.
• Feasibility analysis for placing on the market in the target Country.
• RegToDate – Regulatory Update Service.
• Template.
• Quality Technical Agreement (QTA) draft.
• Regulatory Intelligence.

Strategic Regulatory Consulting

CE Certification Support

Italian and European Ministerial Registrations

International Registrations outside the EU

Local Representative

Quality and International GMPs