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Leuchtenden Harpune Hass closing sequence ectd Ein Picknick haben Gerangel Welle

Blog | LORENZ Life Sciences Group
Blog | LORENZ Life Sciences Group

Guidelines for submission and technical validation of applications
Guidelines for submission and technical validation of applications

New | IDMP version 2.0 has been published
New | IDMP version 2.0 has been published

BfArM - eSubmission - Electronic Common Technical Documents (eCTD)
BfArM - eSubmission - Electronic Common Technical Documents (eCTD)

Electronic Common Technical Document (eCTD) v4.0 TECHNICAL CONFORMANCE GUIDE
Electronic Common Technical Document (eCTD) v4.0 TECHNICAL CONFORMANCE GUIDE

OS000_00_004e_WL Guidance Industry eCTD
OS000_00_004e_WL Guidance Industry eCTD

Dossier requirements for Centrally Authorised Products (CAPs)
Dossier requirements for Centrally Authorised Products (CAPs)

Closing the eCTD gap in one year
Closing the eCTD gap in one year

CMDh Best Practice Guide on the use of the electronic Common Technical  Document (eCTD) in the Mutual Recognition and Decentralis
CMDh Best Practice Guide on the use of the electronic Common Technical Document (eCTD) in the Mutual Recognition and Decentralis

Blog | LORENZ Life Sciences Group
Blog | LORENZ Life Sciences Group

Secrets of eCTD Related Sequences
Secrets of eCTD Related Sequences

January 2015
January 2015

Electronic Common Technical Document (eCTD) v4.0 TECHNICAL CONFORMANCE GUIDE
Electronic Common Technical Document (eCTD) v4.0 TECHNICAL CONFORMANCE GUIDE

January 2015
January 2015

Post Authorisation Guidance-Integrated Version
Post Authorisation Guidance-Integrated Version

QA eCTD variations vers 6 Feb 2015_final
QA eCTD variations vers 6 Feb 2015_final

Closing the eCTD gap in one year
Closing the eCTD gap in one year

eCTD Guidance v4 0-20160318-hv
eCTD Guidance v4 0-20160318-hv

Secrets of eCTD Related Sequences
Secrets of eCTD Related Sequences

ECTD Guidance v3.0 Final Aug13 | PDF | Portable Document Format | Hyperlink
ECTD Guidance v3.0 Final Aug13 | PDF | Portable Document Format | Hyperlink

January 2015
January 2015

BfArM - eSubmission - Electronic Common Technical Documents (eCTD)
BfArM - eSubmission - Electronic Common Technical Documents (eCTD)

Product Management Services (PMS) - Implementation of International  Organization for Standardization (ISO) standards for the ide
Product Management Services (PMS) - Implementation of International Organization for Standardization (ISO) standards for the ide