Submissions

eCTD Electronic Publishing Acorn Regulatory

Outsourced eCTD Publishing Services: An Overview

More countries are implementing eCTD.  As a result, more companies are being forced to make decisions regarding how they manage… Read more

How To In-Licence An eCTD Dossier

We are taking a look at 4 factors to consider when planning to in-licence an eCTD dossier. When acquiring an… Read more

eSubmission eCTD Timeline Acorn Regulatory

What’s Happening with the eSubmission Roadmap?

The eSubmission roadmap is filled with significant dates that can impact on your business.  Here, we look at developments on… Read more

repeat use procedure Acorn Regulatory Regulatory Strategy Consultants

Repeat Use Procedure: What Are The Steps To Consider?

In this article, Christine McGrath, a senior member of our pharmaceutical regulatory affairs team,  looks at the issue of Repeat… Read more

eCTD deadline - Acorn Regulatory

eCTD Deadline: Are You Ready?

The electronic Submission (eSubmission) roadmap has introduced very strict milestones for the mandatory use of eCTD format. Are you aware… Read more

eCTD Electronic Publishing Acorn Regulatory

Outsourcing eCTD in 2019 – Is This The Right Time?

We have referenced it before on our blog: the life sciences sector can learn a lot about outsourcing from the… Read more

Acorn Regulatory The eCTD Deadline is Looming Are You Ready Acorn Regulatory

The eCTD Deadline is Looming: Are You Ready?

For those of us working in the regulatory affairs sector, there is always a deadline to contend with.  We deal comfortably with… Read more

How Do You Translate Your Non-EU dossier For The EU Market_ - Acorn Regulatory

How Do You Translate Your Non-EU Dossier For The EU Market?

The issues faced when translating a non-EU dossier for the EU market is covered in this blog by the CMC… Read more

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DCP Applications To Be Accepted Only in eCTD format from July 1st 2015

Looking back on how far we have progressed from the standard paper submission one thing is clear –  the age… Read more

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