2017 Communication Method Validation 
ISPE
MAY 9, 2023
ANVISA’s analytical method validation 15 and forced degradation 1 requirements are examples of those local regulations that bring additional technical requirements and make a Brazil dossier different from a US or EU dossier (both ICH member countries) and drive the divergence between harmonized global registration process.
ISPE
AUGUST 29, 2022
BioProcess International 15 (September 2017):24–47. Ideally, data and information from multiple regions could be submitted simultaneously, available for all regulatory bodies to access and review as required, thereby allowing regulators to communicate with each other and see previous questions and decisions of other regulatory bodies.
Expert insights. Personalized for you.
52 
Let's personalize your content