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 eCTD Resource Center

 

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WEBINAR: How Standardized Terminology can Accelerate Global Regulatory Performance

June 15, 2022

WEBINAR: Benchmarking Survey - Is EU CTR Driving Tighter Clinical & Regulatory Integration?

March 30, 2022

PRESS RELEASE: Cary Smithson Brings Extensive Life Sciences Regulatory Expertise to Help Phlexglobal Customers Navigate a Transforming Regulatory Landscape

November 11, 2021

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

March 25, 2021

VIDEO: PhlexSubmission Electronic Common Technical Document (eCTD) Software Introduction

 

INFOGRAPHIC: Submission Software Decision Guide

March 11, 2021

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

July 14, 2021

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

November 20, 2020

WHITE PAPER: Industry Survey Results & Expert Analysis

October 29, 2020

VIDEO: PhlexSubmission eCTD Video Demonstration

 

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

May 30, 2021

ARTICLE: Prepare yourself for 2020 – Global regulatory update

December 6, 2019

ARTICLE: Common Promotional Submissions in eCTD Errors and How to Avoid Them

May 28, 2019

ARTICLE: Phlexglobal’s View on eCTD v4.0

October 30, 2018

ARTICLE: Australian regional specification – eCTD Version 3.1

June 14, 2020

ARTICLE: eCTD Health Canada – an Overview

November 28, 2018

ARTICLE: eCTD Brief: The Deep Dive into Electronic Submissions

November 1, 2017

ARTICLE: FDA has published a new guidance on eCTD 4.0

October 5, 2017

ARTICLE: ICH’s Value to Regulatory

August 11, 2017

ARTICLE: eCTD in the Cloud – Risk-Benefit Analysis

February 24, 2015

 

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Clinical Trials and the TMF 101 - Blog 1: Basics of a Clinical Trial

Introduction  Firstly, welcome, it is great to see you here. Thank you for taking the time to check out our new blog series on the basics of Clinical Trials and the TMF. This series is designed to be

FDA and MHRA Say Remote and Hybrid Inspections to Continue

At the 2022 Drug Information Association Annual Meeting, held in-person in Chicago June 20-23, representatives from the compliance offices of the FDA and MHRA gave a detailed assessment of the pros

Examining the Why and How of Integrating Your eTMF and CTMS

Adapted from a Phlexglobal Ask An Expert interactive discussion held May 11, 2022 and available on-demand here.   Why Integrate Your CTMS and eTMF Systems?  A typical electronic Trial Master File

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