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Regulatory Affairs

The set-up and conduct of a study requires professional expertise in working with authorities and ethics committees and their requirements. Detailed regulatory knowledge is necessary to realise a study project in compliance with the respective laws, directives, harmonised norms and regulations.

Professional communication with ethics committees and authorities is crucial to keep a study on schedule. As your qualified partner we liaise with regulatory authorities and ethics committees, prepare the required documentation for submissions and coordinate all study-related regulatory activities.

Irrespective of the study type (trials with drugs or medical devices, with or without intervention, registries, diagnostic or other studies), the applicable regulatory framework must be complied with. To this end, a thorough knowledge of the respective regulations and the organisational competence for optimised submission management is needed.

We have the necessary competence and wide experience to facilitate regulatory affairs in your study project.

The submission of diverse documents and information to ethics committees and authorities during study set-up, conduct and at the end of a study project is required by law. We offer our assistance to the timely communication and submission of documents in line with demand.

Our Regulatory Affairs team comprises qualified and experienced experts who are also prepared to communicate with authorities and ethics committees on your behalf.

Contact

Any questions, interested in our services? Contact us!

Tel.: +49 7071 9992-0