Regulatory Relevant & Scientifically Sound
Our vision is to create a company building on extensive regulatory experience and on firm scientific knowledge. We believe that progress in research and development comes from teamwork and we are committed to bring the regulatory aspects to the table. By including the regulatory aspects early on in the project, the path to market access can be influenced and time to market minimized. All projects are different and there are rarely any standard solutions to the challenges in product development. Even though regulatory guidelines are for everyone to read, our job is to read between the lines and put the current regulatory thinking in the context of the scientific opportunities in the individual project. We will help you look into the future and predict in what direction the regulation is heading.
Our fundamental understanding of the regulatory requirements and current thinking helps us to develop the best regulatory strategy for your product.
We help you design development studies that are consistent with their intended scientific purpose and will gain relevant knowledge for science-based regulatory submissions.
By combining the understanding of regulatory demands and market dynamics with scientific knowledge we identify the critical steps to be performed and how to present the obtained results in a manner suitable for regulatory and business evaluation.