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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Data Mining as the First Touch Point with AI

Artificial Intelligence is enabling businesses all over the world to create new value from their existing data. Data ...

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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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Regulatory Information Management - the Compliance & Efficiency Union

While the opinions about the information model for Regulatory Information Management vary and are subject to many ...

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Drug Master File – Count Down

The FDA deadline on NDA, ANDA, BLA and DMF (paper submissions) is less than 4 weeks away. By 5th of May 2017 the FDA ...

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IDMP Update

News and updates from the SPOR Task Force Meeting held on 10 March 2017. As previously communicated, OMS and RMS UAT ...

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