How to approach drug substance supply in new product introduction (NPI) processes
by Giuliana Miglierini A key issue to be faced during pharmaceutical development refers to the supply of the…
EMA’s consultation on draft Q&As on remote certification of batches by QP
by Giuliana Miglierini The last two years saw the implementation of a high degree of regulatory flexibility as…
The new Annex 21 to GMPs
by Giuliana Miglierini The new Annex 21 to GMPs (C(2022) 843 final) that EIPG gave a significant contribution…