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
Thanks so much for your support over the past 30 days. Your commitment and timely communication have made working with you all a pleasant experience.
Senior QA Associate
There was a close relationship between the regulatory strategy and the writing activities. You developed a fine-tuned regulatory strategy which will be a key factor to smooth the approval of our dossier.
VP Regulatory Strategy