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
In these unprecedented times, PharmaLex continues to support all clients by meeting virtually and providing experienced, remote-based consultants.
I just wanted to relay our sincere thanks to you and the team for two really excellent days training. It was well organized and structured to cover regulatory expectations, GMP principle and routine work challenges of industry. The presenters and moderator were highly skilled in this area to accommodate any queries raised during the training session and were well able to keep the team engaged even in remote/virtual training session. The design of training slides was impressive and the use of technology to make virtual training was remarkable.
Compliance Lead, Qualified Person, Amneal Ireland Limited