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Blog | LORENZ Life Sciences Group
UC Effect Changes Design
CMDh Best Practice Guide on the use of the electronic Common Technical Document (eCTD) in the Mutual Recognition and Decentralis
New | IDMP version 2.0 has been published
Dossier requirements for Centrally Authorised Products (CAPs)
January 2015
January 2015
Secrets of eCTD Related Sequences
Procedural announcements
BfArM - eSubmission - Electronic Common Technical Documents (eCTD)
Secrets of eCTD Related Sequences
Advance notice - update to an eCTD file download for version 3.1 | Therapeutic Goods Administration (TGA)
ECTD Guidance v3.0 Final Aug13 | PDF | Portable Document Format | Hyperlink
January 2015
BfArM - eSubmission - Electronic Common Technical Documents (eCTD)
eCTD Guidance v4 0-20160318-hv
Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the ide
Closing the eCTD gap in one year
Electronic Common Technical Document (eCTD) v4.0 TECHNICAL CONFORMANCE GUIDE
Guidelines for submission and technical validation of applications
Post Authorisation Guidance-Integrated Version
Closing the eCTD gap in one year
eCTD EAEU
Centralised Procedure Process Timetable
Closing the eCTD gap in one year
Secrets of eCTD Related Sequences
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