Getting the best out of a Scientific Advice from Health Authorities
Having provided Scientific Advice for more than 150 clients over the last five years, PharmaLex has considerable experience in leading clients through the Scientific Advice process, with FDA in the US, the EMA in the EU and other major Health Authorities in- and outside of the EU.
We are specialized in assisting clients in navigation of Health Authority requirements, and support them throughout the Scientific Advice process, facilitated by our local country-based affiliates and partners who can provide local procedural guidance and logistical support.
What our clients say
We couldn’t have asked for a more professional, personable, knowledgeable group of Quality Experts!
Drug Safety Director
Able to explain technical details so non-experts can understand