Prepare yourself for 2020 – Global regulatory update

With an ever-increasing regulatory landscape, it is important to know what is coming next. Looking into regulatory ...

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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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How New EU Regulations Will Impact Regulation of Medical Devices

The adoption of Regulation (EU) 2017/745 on Medical Devices (MDR) and Regulation (EU) 2017/746 on In-Vitro Diagnostic ...

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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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