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Read more about the article Ennov Ready to Support Customers in EMA eCTD 4.0 Customer Pilot Phase 

Ennov Ready to Support Customers in EMA eCTD 4.0 Customer Pilot Phase 

  • Post author:Alp Tetikel
  • Post published:July 9, 2025
  • Post category:Ennov News/Regulatory - Blog

The EMA’s eCTD 4.0 pilot is entering its next stage, and Ennov is ready to support Marketing Authorization Holders (MAHs) who are participating.  Following our own successful test submission during…

Continue ReadingEnnov Ready to Support Customers in EMA eCTD 4.0 Customer Pilot Phase 
Read more about the article Preparing for eCTD 4.0 in Japan with a Global Pharma Leader 

Preparing for eCTD 4.0 in Japan with a Global Pharma Leader 

  • Post author:Alp Tetikel
  • Post published:July 9, 2025
  • Post category:Blog/Regulatory - Blog

The Challenge  Japan’s move to eCTD 4.0 has created more questions than answers for pharmaceutical companies. For one of the world’s premier pharmaceutical companies, the goal is to be ready…

Continue ReadingPreparing for eCTD 4.0 in Japan with a Global Pharma Leader 
Read more about the article eCTD 4.0 Pilot Readiness Checklist

eCTD 4.0 Pilot Readiness Checklist

  • Post author:Alex Chappell
  • Post published:February 12, 2025
  • Post category:Insider/Regulatory

eCTD 4.0 is one of the main focal points of the regulatory world, and participating in an eCTD 4.0 pilot is a great opportunity to get experience with the future of regulatory submissions. Make sure you’re prepared and get the most out of your pilot experience!

Continue ReadingeCTD 4.0 Pilot Readiness Checklist
Read more about the article Global eCTD Regulatory Updates

Global eCTD Regulatory Updates

  • Post author:Alex Chappell
  • Post published:October 28, 2024
  • Post category:Insider/Regulatory

The eCTD framework is evolving—and with it, new requirements, tools, and harmonization efforts impact regulatory submissions worldwide.

Continue ReadingGlobal eCTD Regulatory Updates
Read more about the article Ennov Dossier

Ennov Dossier

  • Post author:Chet Shemanski
  • Post published:April 24, 2023
  • Post category:Regulatory

Effortlessly build, manage, and publish regulatory dossiers. Simple drag-and-drop interface, submission assembly templates, regular updates.

Continue ReadingEnnov Dossier
Read more about the article FDA News Roundup for Reg Affairs-Reg Ops

FDA News Roundup for Reg Affairs-Reg Ops

  • Post author:Kathie Clark
  • Post published:August 19, 2022
  • Post category:Blog/Regulatory - Blog

In the past six months, the FDA has issued a number of guidance documents (both draft and final) of interested to Reg Affairs and Reg Ops.

Continue ReadingFDA News Roundup for Reg Affairs-Reg Ops

FDA eCTD-Related News

  • Post author:Kathie Clark
  • Post published:October 14, 2021
  • Post category:Regulatory - Blog

At Ennov’s recent Regulatory User Group meeting, my colleague Steve Clark provided an update on regulatory news covering the last six months.  Our users appreciated the information – everyone tries…

Continue ReadingFDA eCTD-Related News
Read more about the article Case Study: Laboratoire Aguettant

Case Study: Laboratoire Aguettant

  • Post author:Chet Shemanski
  • Post published:November 30, 2020
  • Post category:Regulatory

Aligning regulatory activities to strengthen competitive position.

Continue ReadingCase Study: Laboratoire Aguettant

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