The US Food and Drug Administration and the European MedicinesAgency offer expedited regulatory approval programs for drugs with high potential patient value applicable at different stages leading to marketing authorization.
Read the abstract here
Clinical development time via accelerated approval in the US or conditional approval in the EU
We have offices in Oss and Amsterdam
Zwiers Regulatory Consultancy is a ProductLifeGroup Company
ProductLife Group’s mission is to improve human health by delivering regulatory & compliance services for the safe and effective use of medical solutions. PLG supports clients through the entire product life cycle, combining local expertise with global reach spanning more than 150 countries.
