January 2015
Closing the eCTD gap in one year
ECTD Guidance v3.0 Final Aug13 | PDF | Portable Document Format | Hyperlink
Secrets of eCTD Related Sequences
Procedural announcements
Electronic Common Technical Document (eCTD) v4.0 TECHNICAL CONFORMANCE GUIDE
CMDh Best Practice Guide on the use of the electronic Common Technical Document (eCTD) in the Mutual Recognition and Decentralis
January 2015
Blog | LORENZ Life Sciences Group
Post Authorisation Guidance-Integrated Version
Electronic Common Technical Document (eCTD) v4.0 TECHNICAL CONFORMANCE GUIDE
Dossier requirements for Centrally Authorised Products (CAPs)
Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the ide
QA eCTD variations vers 6 Feb 2015_final
eCTD Guidance v4 0-20160318-hv
January 2015
January 2015
Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the ide
New | IDMP version 2.0 has been published
Guidelines for submission and technical validation of applications
BfArM - eSubmission - Electronic Common Technical Documents (eCTD)
eCTD Guidance v4 0-20160318-hv
Blog | LORENZ Life Sciences Group
