For those countries, which wish to conduct clinical research in the United States, an IND is required regardless of the proposed phase of clinical trial. Thus, even phase 1 trials to be conducted in the United States on volunteer subjects require the prior submission of an IND before that ...
Eight years after its adoption, the EU Clinical Trial Regulation (CTR) 2022 has come into full application, radically altering the regulatory landscape for conducting clinical trials in EU member states and European Economic Area (EEA) countries. This whitepaper provides insight into the key changes...
We know the specific differences of EU- and US-dossiers and have long term experience in preparing global dossiers. This way we can help you to find the most efficient way in preparing your dossier for submission in various countries all over the world. We will also guide you through the ...