Competent Authority Submissions
Our regulatory team has in-depth experience in dealing with the procedures and documentation required for Competent Authority submissions throughout Europe.
This local expertise and familiarity with the submission process can help ensure that submitted Clinical Trial Applications (CTAs) are complete and accurate, as required by the EU Clinical Trials Directive (EU Directive 2001/20/EC).
We can also support other applicable regulatory requirements such as FDA regulations.
This can help prevent unnecessary delays occurring as a result of incomplete or incorrect submissions. If you require assistance with Authority Submissions for clinical trials, why not call us now to discuss the process?