In pharmaceutical research, the Regulatory Affairs sector includes the application for approval / a positive opinion regarding the conduct of a clinical trial, the subsequent steps such as the reply to deficiency letters, notification of authorities, and also the information about the termination of the trial.

In terms of the medical devices sector, Regulatory Affairs include all activities dealing with the initial market authorization (conformity assessment procedures), clinical trials, and clinical evaluations as well as the generation and the maintenance of the technical documentation, the quality and risk management and the activities following the market authorization within the framework of the post-market surveillance.