Resources - eCTD

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CUSTOMER STORY

Treximo Selects Phlexglobal's Innovative Submission Software as Technology Foundation Supporting Strategic Growth in Regulatory Services

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March 25, 2021

eCTD

WEBINAR

From File to Trial to File: Benefits of an Integrated Clinical and Regulatory Perspective

 

 

 

WATCH

January 20, 2021

eCTD; TMF; RIM/IDMP

VIDEO

PhlexSubmission Electronic Common Technical Document (eCTD) Software Introduction

 

 

WATCH

 

eCTD

CUSTOMER STORY

Hope Biosciences Stem Cell Research Foundation Selects Phlexglobal to Support Rapid, Compliant New Drug Application for COVID-19 Therapy

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November 20, 2020

eCTD; TMF; RIM/IDMP, Automation

WHITE PAPER

Industry Survey Results & Expert Analysis

 

 

 

 

 

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October 29, 2020

eCTD; TMF; RIM/IDMP, Automation

DATA SHEET

PhlexSubmission  (eCTD) Software: Create new or import existing electronic submissions with ease.

 

 

READ

 

eCTD

WEBINAR

Innovation Tour Survey Results Panel: Future Trends in TMF, IDMP, and eCTD

 

 

 

WATCH

October 29, 2020

eCTD; TMF; RIM/IDMP, Automation

ARTICLE

Prepare yourself for 2020 – Global regulatory update

 

 

 

 

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December 6, 2019

eCTD, RIM/IDMP

VIDEO

PhlexSubmission eCTD Video Demonstration

 

 

 

 

 

WATCH

 

eCTD

ARTICLE

Common Promotional Submissions in eCTD Errors and How to Avoid Them

 

 

 

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November 20, 2019

eCTD

ARTICLE

Health Canada revises validation rules for eCTD format

 

 

 

 

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May 28, 2019

eCTD

ARTICLE

Phlexglobal’s View on eCTD v4.0

 

 

 

 

 

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October 30, 2018

eCTD

ARTICLE

Australian regional specification – eCTD Version 3.1

 

 

 

 

READ

June 14, 2018

eCTD

ARTICLE

eCTD Health Canada – an Overview

 

 

 

 

 

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November 28, 2017

eCTD

ARTICLE

eCTD Brief: The Deep Dive into Electronic Submissions

 

 

 

 

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November 1, 2017

eCTD

ARTICLE

FDA has published a new guidance on eCTD 4.0

 

 

 

 

 

READ

October 5, 2017

eCTD

ARTICLE

ICH’s Value to Regulatory

 

 

 

 

 

 

READ

August 11, 2017

eCTD

ARTICLE

eCTD in the Cloud – Risk-Benefit Analysis

 

 

 

 

 

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February 24, 2015

eCTD

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