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DOCmanager
eCTD
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eCTD General
DOCmanager
DOCmanager is the perfect add-on to eCTDmanager! Users can maintain a master-child relationship between DOCmanager templates and dossiers in eCTDmanager. DOCmanager supports parallel updates on many identical or nearly identical submissions,...
eCTDmanager Basic Training Course
eCTD
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eCTD General
eCTDmanager Basic Training Course
This course targets users who want to get an overview of the eCTDmanager basic features. Based on your valuable feedback from the COVID-19 free eLearning we revised the course completely for the eCTDmanager version 7.0! During this course we...
eCTDmanager Basic: Additional Features for US FDA Submissions
eCTD
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eCTD USA
eCTDmanager Basic: Additional Features for US FDA Submissions
In the following sessions we’ll focus on US specific features. This course is an enhancement to the eCTDmanager Basic Training course for EU. Topics featured here are: 1) Additional configuration steps in eCTDmanager 2) The US Module 1...
eSUBmanager/EURSnext Basic Training Course
eCTD
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eCTD General
eSUBmanager/EURSnext Basic Training Course
"EURSnext" was designed for the assessors and reviewers in health authorities, who have to assess and review the electronically created Sequences with regards to quality, safety and efficacy. "eSUBmanager" is the identical tool for the same use...
EURS - The EXTEDO Universal Reviewing System
eCTD
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eCTD General
EURS - The EXTEDO Universal Reviewing System
The reviewing of electronic submissions upon receipt is a critical process for regulatory authorities. EXTEDO EURS provides you with tools for the validation, acceptance, import, review and maintenance of eCTD, NeeS-based and non-eCTD...
EURSValidator Global Basic Training
eCTD
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eCTD General
EURSValidator Global Basic Training
Before you submit your sequences to the health authorities, you must ensure that you comply with their regulatory standards. If you fail to comply with any of their validation criteria, your submission might be rejected by the authority. The...
SafetyEasy PV
Pharmacovigilance
SafetyEasy PV
EXTEDO SafetyEasy™ PV offering is a comprehensive and cost-effective solution designed to streamline pharmacovigilance processes within regulated organizations. It provides the ability to classify, create, review, submit and maintain...

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