Regulatory Affairs are essential from the planning of a trial to its completion and cover clinical trials (CT) as well as non-interventional studies (NIS).
We offer full regulatory services for Germany/Austria and fully supports applications to Swiss regulatory authorities and ethics committees. Our experienced regulatory affairs team takes care that all applicable laws and regulations are adhered to at any stage of a study. All documents are accurately reviewed to ensure completeness and consistency with regulatory requirements.
We will be pleased to advise you on single regulatory issues or the entire process.
You may engage our full service working hand in hand with the project management including all applications/notifications necessary in a study or just a part of it.
Our regulatory affairs services include:
- Clinical Trials concerning medicinal products, medical devices or foods:
compilation of clinical trial application dossiers, application to competent authorities for approval, obtaining favourable opinion of ethics committees, notifications to local authorities
- Non-Interventional Studies (NIS):
submission for obtaining a favourable assessment of the ethics committees, notification/application to competent authorities according to legal requirements and notification to applicable statutory corporations
- Updating service during ongoing projects
- Review of study documents (protocol, patient information sheets/informed consent forms, drug labels, etc.) to ensure they have been prepared according to regulatory requirements
- Support for clinical studies concerning pharmacovigilance
- Consulting on regulatory questions