Submitting studies to the regulatory bodies such as ethics committees and authorities can be challenging. Following the full enactment of CTR 536/2014 and the launch of the CTIS portal on 30 January 2022, we expect to see the implementation of the intended harmonization of the submission process for clinical trials within the EU. Despite this progressive harmonization of the regulatory environment, there are still local requirements to consider. The application for authorisation of clinical studies, regardless of the respective type of clinical study, is time-consuming and cost-intensive. Against this background, a reliable partner with extensive regulatory experience is indispensable.