Common Promotional Submissions in eCTD Errors and How to Avoid Them

Recently, the FDA held a free webinar in its CDER Small Business and Industry Assistance (SBIA) Webinar Series on “OPDP ...

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Health Canada revises validation rules for eCTD format

As part of our continuous global regulatory updates and in case it did not catch your attention, please be reminded on ...

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Phlexglobal’s View on eCTD v4.0

eCTD has been around for nearly 20 years and we’ve seen how it has transformed the regulatory submission landscape. The ...

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Australian regional specification – eCTD Version 3.1

Australia is phasing out eCTD Specification version 3.0 on 30th June 2018. The Therapeutic Goods Administration (TGA) ...

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eCTD Health Canada – an Overview

eCTD becomes more and more mandatory in different regions and for various submission types. Soon only the eCTD format ...

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eCTD Brief: The Deep Dive into Electronic Submissions

The ICH Common Technical Document (CTD) provides a common format for marketing authorization submissions in all ICH ...

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