The EU Clinical Trial Regulation (CTR) applies as of 31 January 2022. Meanwhile PhaseUp has experience with preparation, submission and conduct of studies under CTR.
Phaseup also has experience in obtaining the required permits for clinical drug research for ATMPS in the Netherlands, such as for clinical gene therapy studies. Obtaining these permits requires involvement of the Ministry of Infrastructure and Watermanagement (IenW) and the Office for Genetically Modified Organisms (GMP Office).