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 […]

Our CEP has been accepted and its certificate granted! Many thanks to Acorn Regulatory for the tremendous work that was done. Your strength, patience and flexibility in working with us was paramount in this success.

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 […]

DMF deadline FDA building Acorn Regulatory

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 […]

Outsourcing eCTD - Mandatory eCTD

Mandatory eCTD: What You Need To Do

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

eCTD Baseline Submissions

eCTD Baseline Submissions

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

The eSubmission Roadmap - What Is Happening Between Now and 2020-

The eSubmission Roadmap – What Is Happening Between Now and 2020?

The January 1st 2018 eCTD deadline is just one critical date that forms part of the overall eSubmission roadmap that […]

eCTD Deadline - Acorn Regulatory

eCTD Deadline: Are You Ready?

Are you ready for the mandatory implementation of eCTD format for regulatory submissions? The deadline is quickly approaching and many […]

Outsourcing eCTD - Mandatory eCTD

Outsourcing eCTD – 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 […]

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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