Prepare your clinical trial application and be ready for the new EU Clinical Trials Regulation.
SFL’s regulatory affairs and medical affairs team can provide regulatory advice and hands-on support for application of clinical trials evaluating drugs, biologics and advanced therapy medicinal products (ATMPs) including gene therapy products.
The new EU Clinical Trials Regulation (CTR) and the Clinical Trials Information System (CTIS) that will become applicable in January 2022 will have significant impact on the authorization, management and supervision of clinical trials in the EU.
It is therefore of utmost importance for clinical trial sponsors to prepare for the entry into application of the CTR and to make sure they meet the new requirements under the Regulation and know how to navigate the CTIS.
Our regulatory affairs team is well attuned to the CTR and its CTIS and can support you with strategic and operational advice to ensure your company’s full readiness.