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 years. Many visitors to our website submit questions on regulatory issues. In this blog post, Eileen Ryan, our Regulatory Publishing...
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 that we have covered on this website on a number of occasions. The next deadline of note is that of...
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 Type III Drug Master Files (DMF’s) in eCTD has been delayed until May 5th 2019.
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 very first companies to embark on electronic publishing on behalf of client companies many years ago. As the eSubmission Roadmap...
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 to ensure that the project was completed as efficiently as possible. Recently, the client contacted us to say “Our CEP...
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 article we look at mandatory eCTD and what you need to do.
eCTD Baseline Submissions
In this article we look at eCTD Baseline Submissions and the issues relating to the January 1st 2018 deadline.
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 of the deadlines that have passed or the deadlines that are approaching? So, What does the eSubmission roadmap entail? The...
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 airline industry. In particular, companies should consider outsourcing eCTD projects.
The eCTD Deadline is Looming: Are You Ready?
For those of us working in the regulatory affairs sector, there is always a deadline to contend with. We deal comfortably with client deadlines every day. However, the new deadlines that are causing the most unease in the life sciences sector are...
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