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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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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SPOR Update 2018 – News from the EMA webinar

The implementation process of SPOR over several phases… that’s nothing new. However, after the 6-month delay due to the ...

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The Challenge with EMA’s Changing Timelines for IDMP

A combination of factors has resulted in the shifting timeline of EMA’s implementation of the IDMP data collection. One ...

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Electronic Application Forms (eAF) update

Since January 1st 2016, all Submissions to the European Union have to include electronic application forms instead of ...

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European eCTD Module 1 Version 3.0 Finalized

EMA eCTD specifications – General Update In October, EMA has officially released the version 3.0 of the European Module ...

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