Makes your life easier
If your internal DRA department needs temporary support, we can carry out customer and process-specific work cost-effectively. If you lack the resources for a temporary project that needs to be completed on time, we can relieve you at short notice with our expertise.
We carry out all the necessary routine work for you in connection with the marketing authorization dossier. This includes the efficient management of the marketing authorization dossier, the effective administration of correspondence with authorities and the prompt response to inquiries from authorities. We relieve you of the burden of monitoring deadlines (time management) and regulatory requirements (keeping up to date), as well as essential compliance checks. We support you with our specific technical knowledge in the evaluation, procurement, qualification and validation of an eCTD tool. In doing so, we always focus on our goal: satisfied customers, high quality, lean processes and minimal waste.