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… Read more

Your eCTD Questions Answered

Acorn Regulatory’s publishing team is staffed by eCTD experts.  We have assisted many companies in their eCTD projects in recent… 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

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… Read more

eCTD Baseline Submissions

eCTD Baseline Submissions

In this article we look at eCTD Baseline Submissions and the issues relating to the January 1st 2018 deadline.

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

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