Clinical Trial Submissions

genae supports sponsors and investigators by identifying the stakeholders that need to be involved in the application reviewing process, such as EC's, IRB's, National Competent Authorities and FDA.

The global regulatory authority submission process - through all its phases - is smoother with a proven partner. We invest in your submission’s success with our team of experienced regulatory leaders. Your submissions are backed by broad experience and specialized expertise in a wide range of therapeutic areas and indications.


Mathias Vrolix

I’ve seen genae evolve from being a start-up CRO just more than 10 years ago to the global, important player it currently is in the medical device field.

​​​​​​​— Dr. Mathias Vrolix
​​​​​​​Head department Cardiology & Interventional Cardiology
​​​​​​​East Limburg Hospital, Belgium


genae supports sponsors and investigators by identifying the stakeholders that need to be involved in the application reviewing process, such as Ethical Committees (EC), Institutional Review Boards (IRB), National Competent Authorities and FDA. Expert knowledge of local legislation and a good relationship with the different agencies is crucial for a successful trial submission.

Feel free to contact us so we can further help you with your Clinical Trial Submissions.

How can we help you?

Want to hear more about our services or how we can support your project? Feel free to contact us with any questions you may have.

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