- Audits of registration files for drugs and 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 new EU Directives
If you are interested to know more about our company and expertise, or discuss how we can assist you in regulatory affairs, please contact us: info@profess.nl