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 can assist in identifying opportunities, challenges and risks associated with the drug development program, and help to develop mitigation strategies.
Our advisors are experienced in interpreting the global regulatory framework from a scientific and business perspective with specific focus on the EU and US markets. We also have insight and experience in regulatory requirements for other geographical areas.
We will help you look into the future and predict in what direction the regulation is heading.