eCTD

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 their manage… Read more

PSUSA Deadline How To Guide

How To Prepare For A PSUSA Deadline

Do you have a PSUR Single Assessment (PSUSA) submission deadline approaching?  If so, our Regulatory Publishing Manager, Eileen Ryan, has… Read more

What To Consider When Planning To In-Licence An eCTD Dossier?

In this article we are taking a look at 4 factors to consider when planning to in-licence an eCTD dossier…. 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

Your eCTD Questions Answered

Acorn Regulatory’s publishing team are eCTD experts.  We have assisted many companies in their eCTD projects in recent years.  Many… Read more

DMF Deadline

The US FDA DMF Deadline: 5 Things You Need To Know

The transition from paper based submissions to electronic Common Technical Document (eCTD) has continued in recent years.  This is something… Read more

Focus on DMF & eCTD Acorn Regulatory

Focus on DMF, eCTD & Electronic Publishing

The decision by the US Food & Drug Administration (FDA) to delay the requirement for companies to submit all new… Read more

baseline submissions Acorn Regulatory

Baseline Submissions & The January 1st NeeS Deadline

We have written extensively on issues relating to electronic publishing of submissions.  In fact, Acorn Regulatory was one of the… Read more

Case Study_ How To Obtain A Certificate of Suitability (CEP) - Acorn Regulatory

Acorn Regulatory Case Study: Obtaining A Certificate of Suitability (CEP)

We  worked with a major US manufacturing firm to obtain a CEP.  Our team worked closely with the manufacturing company… Read more

Contact us and enjoy a faster, smoother journey through the maze of European Pharmaceutical and Medical Device legislation with us as your expert guide.
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