Articles tagged with “regulatory-dossier”

EMA eCTD Gateway: A Guide to Technical Specifications

Learn the EMA eCTD Gateway specifications for regulatory submissions. This guide explains the technical architecture, AS2 protocols, validation, and file requir

35 min read

1/13/2026

ema esubmission gateway ectd submission regulatory affairs european medicines agency as2 protocol marketing authorization ectd v4.0 regulatory dossier