Outsourced eCTD Publishing Services: An Overview
More countries are implementing eCTD. As a result, more companies are being forced to make decisions regarding how they manage their electronic submission and eCTD publishing services. We typically encounter three scenarios: Companies that maintain control of electronic publishing at...
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How To In-Licence An eCTD Dossier
We are taking a look at 4 factors to consider when planning to in-licence an eCTD dossier. When acquiring an existing marketing authorisation that is already in eCTD there are some important factors to consider carefully. For instance, the eCTD...
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 the eSubmissions roadmap up to 2020.
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Repeat Use Procedure: What Are The Steps To Consider?
In this article, Christine McGrath, a senior member of our pharmaceutical regulatory affairs team, looks at the issue of Repeat Use Procedures. We explain what a Repeat Use Procedure is, the steps to take, and the pitfalls to avoid in...
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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How Do You Translate Your Non-EU Dossier For The EU Market?
The issues faced when translating a non-EU dossier for the EU market is covered in this blog by the CMC team at Acorn Regulatory.
DCP Applications To Be Accepted Only in eCTD format from July 1st 2015
Looking back on how far we have progressed from the standard paper submission one thing is clear – the age of the electronic common technical document is upon us. For instance, according to the eSubmission roadmap published, as of the 1st...
