Medicinal Products - Medical devices
Product Development
Do you require advice on regulatory or scientific matters in relation to the development or authorisation of your medicinal product, or in preparation for certification of your medical device?
Clinical Trials
Together with our cooperation partners, we provide assistance during the planning and implementation of clinical trials.
Scientific and Regulatory Advice through the Competent Authority
- Scientific Advice Meeting
We can arrange a scientific advice meeting with the competent authority for you, e.g. in order to address questions relating to the pharmaceutical quality, the assessment of medical devices and the planning and implementation of (pre-)clinical studies on medicinial products and medical devices.
- Pre-submission Meeting
We can also arrange an advisory meeting prior to submission of an authorisation application, which will help you to clarify questions regarding the planning and conduct of a concrete, forthcoming marketing authorisation application.Possible topics are the legal basis of the application, the dossier presentation (structure, content) and procedural aspects, as well as the draft labelling.
