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eCTD

PSUSA Deadline How To Guide

Advice for Companies with PSUSA Deadlines Approaching

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

What Are The Key Factors To Consider When Planning To In-Licence An eCTD Dossier?

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

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 […]

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 […]

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 […]

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 […]

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 […]

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 […]

Mandatory eCTD_ What You Need To Do - Acorn Regulatory

What You Need To Know About Mandatory eCTD

  Now that eCTD is mandatory, you need to ensure that your dossiers are in the eCTD format.  In this […]

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