eCTD

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 […]

eCTD Baseline Submissions

eCTD Baseline Submissions

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

eCTD deadline - Acorn Regulatory - esubmission roadmap

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

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

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 […]

Outsourcing eCTD

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 […]

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