Project Description

submission of studies and regulatory requirements for authorities and ethics committees

Submitting trials to the regulatory bodies such as ethics committees and authorities can be challenging. Despite ongoing harmonisation within the regulatory environment, you are faced with a plethora of local regulations and guidelines – and the regulatory submission process is fraught with potential obstacles. Against this background, it is vital that you can call upon a partner with extensive regulatory experience in tackling these very issues. A partner like GKM.

Our team of regulatory experts reviews all submission documents thoroughly to minimise the risk of delays due to incomplete or inaccurate regulatory applications. Our effective application and submission processes for clinical trials and non-interventional studies comply fully with all regulatory requirements. And if ethics committees or authorities request clarification on certain aspects of your project, we will be there to offer any regulatory, medical or statistical support and assistance you may need. We are your reliable partner – for studies at both national and international levels.