Di Renzo Regulatory Affairs is an Italian company that provides consulting services in various regulatory areas including medicines for human and veterinary use, medical devices, in vitro diagnostics, biocides, food supplements and cosmetics. The company has a large staff of technical experts based in Rome with a branch office in Milan and London.
Di Renzo Regulatory Affairs collaborates with companies seeking to enter the European markets and represents them at the agencies and organizations responsible for issuing the necessary authorizations.
In the field of medical devices, Di Renzo Regulatory Affairs has established a team of biomedical engineers, chemists, pharmacists and administrators able to prepare and suitably adapt the documentation from the company in order to obtain the CE mark, in addition to supervising the necessary administrative procedural steps.
- The activities that this unit is able to offer are essentially the following:
- Advice on current Italian and European legislation
- Advice for obtaining the CE mark from Notified Bodies according the 93/42 EU Directive (MDD)
- Examination of technical-scientific documentation and insertion into the National Data Base
- Requests for free sale certificates
- Revision of advertising material and assessment of compliance with current legislation and guidelines
- Application requesting authorisation for advertisements
- Consultancy, development and/or revision of technical dossiers
- Development of quality systems to comply with MDD
- Development of clinical expertises or from literature
- Consultancy regarding clinical trials
Please feel free to visit us at the Bomi Group booth (Pavilhão Azul, Road 06/08) where some delegates of Di Renzo Regulatory Affairs will be happy to provide you with any additional information.
