NeuroScios has accumulated considerable know-how in drug and medical device regulations.

Working at the complex interface between science, business planning, ethics committees, and government authorities, we provide expert strategic advice and can prepare regulatory documents for submissions to the European Medicines Agency and the U.S. Food and Drug Administration.

NeuroScios can plan and handle Scientific Advice procedures at the EMA and the FDA, during which regulators commit themselves to a framework of requirements on which developers can plan the regulatory effort.