has experience in obtaining the necessary permits for clinical drug research (including ATMPs) and clinical research with medical devices:
- Assistance with submission of the permit application to the Ministry of Infrastructure and Water Management (required for gene therapy)
- Submission of study documents to obtain a statement of no objection from the competent authority (CCMO or Ministry of Health, Welfare and Sport)
- Submission of Research file to obtain a positive assessment from the Ethics Committee (METC or CCMO)
can also be of service to you in other activities in the field of clinical drug research and research with medical devices.
New European ethical considerations for research with minors.