Chris Englerth

Recent Posts

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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Highlights from the 2019 US TMF World Forum

In early October, Phlexglobal was honored to welcome industry TMF professionals from over thirty pharmaceutical ...

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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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FDA at DIA RSIDM 2019 – Presentations Highlights

As part of the DIA RSIDM conference in Bethesda, ML in February 2019, the following comprehensive list summarizes our ...

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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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