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
I just wanted to let you know that the recent EU Codes webinar was excellent. Rina presented a very complex and grey topic in the most clear and digestible manner – a sign of a true expert. The questions in the Q&A were sometimes a little ambiguous but Rina gave clear and relevant answers that provided real clarity.
Medical Team Leader, Multi Tumor Franchise Roche Products Ltd
Pharmalex provided the resources we needed to compile Investigational Medicinal Product Dossiers for our biological products. The dossiers were delivered on time with the trusted quality we expected
Sr Director Regulatory Affairs CMC