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. 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.

Regulatory relevant

Our fundamental understanding of the regulatory requirements helps us identify which scientific studies that are relevant for your specific product and when the information is needed from a regulatory point of view.

Scientifically sound

Development studies should be consistent with their intended scientific purpose and designed to gain the relevant knowledge for a science-based regulatory submission.

Fit-for-purpose

By combining regulatory understanding and scientific knowledge of your product we identify the critical studies to be performed and how to present the obtained results in a manner suitable for regulatory evaluation.