When preparing your eCTD submission, every little helps. An eCTD (electronic Common Technical Document) submission is after all an extremely complex process, with the tender of regulatory information such as applications, reports and supplements, and the associated documentation and cross-links required, needing to be technically accurate for submission success. That’s where eCTD templates come in.
In this blog post, we take a closer look at the use of eCTD templates, the benefits they unlock and why our predefined eCTD Word templates are your route to streamlining your eSubmission.
What are eCTD templates?
eCTD templates are structured documents that provide step-by-step guidance. Using a common structure and easy-to-use toolbar, eCTD templates ensure a one-click approach to configuring and populating an eCTD submission in the standardised format.
What are the benefits of using eCTD templates?
eCTD templates provide great starting points for regulatory writers, helping them prepare a specialised document to unlock several advantages. Here the European Medical Writers Association explains more about just one of the key benefits that can be harnessed via template use:
“In the pharmaceutical industry, templates have a more specific and crucial function – guidance compliance. Regulatory templates are supposed to be designed to comply with the eCTD format requirements and to facilitate electronic submissions by providing correct section numbering and headings.”
eCTD submission standards are updated regularly. But with an eCTD template in tow, you’ll instantly have access to and knowledge of the current local and global regulations and requirements that are relevant to your organisation via up-to-date guidance text.
In addition to ensuring regulatory compliance, the use of a standardised eCTD template provides the consistency regulatory writers need to deliver different documents with a uniform look. The right template means your writers will spend less time formatting the document and more time developing the content within. This high level of consistency also paves the way for documents to be written, managed and edited by different writers to increase efficiency as a whole.
Speed is another plus point to using eCTD templates. Complex tasks that would usually take several clicks to complete can be undertaken with one or two clicks thanks to the simplification of critical formatting.
How can I find the eCTD template that’s right for me?
You don’t have to search too far for an excellent eCTD template that will serve your regulatory writers and wider organisation well. Our MS Word eCTD templates have an enviable reputation and can help you save significant time and resources. Our eCTD template suite offers granular module 1 to 5 templates, pre-populated eCTD metadata, pre-defined headings and tables (with numbering), and headers and footers.
All these features ensure the creation and insertion of tables, tables of contents, cross-references, batch updates and text can be completed with ease and efficiency.
To find out more about how our eCTD template suite can help streamline your submission process, please get in touch with us today.