Challenge of cmc regulatory compliance for biopharmaceuticals, the
Auteur :
Geigert, John
Éditeur :
Springer Nature Switzerland AG
ISBN :
9783032252821
Date de publication :
3 juil. 2026
Dimensions :
23,5 x 15,5 cm
Langue :
Anglais
Pays d'origine :
Suisse
Regulatory authorities, primarily the U.S. FDA and the European EMA, have responded to this increasing CMC regulatory compliance complexity of biopharmaceuticals, and have issued over 150 new or updated regulatory guidelines since the publishing of the previous edition.