Regulatory Affairs consultancy

Assistance can be offered with respect to:

• Writing clinical study reports
• Audits of registration files for drugs and technical files for medical devices
• Feasibility of the file in the respective country in Europe
• Advice on how to update the file
• Preparation of the registration file
• Preparation of variations and Periodic Safety Update Reports
• Design of Module 2 documents of the Common Technical Document
• Contact with European Competent Authoritities and Notified Bodies
• Certification of medical devices according to Medical Device Regulation