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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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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What To Know Before You Migrate a Trial Master File

Adapted from a March 2019 Phlexglobal webinar. For an in-depth look at the topic of migrating TMF data, view the ...

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EMA’s Trial Master File Guidance is in Effect. Are You Ready?

Adapted from an April 2019 Phlexglobal webinar presented by Eldin Rammell. For a more detailed discussion of the new ...

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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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