Longer lifecycles call for better quality – changing your eCTD publisher might be the solution


Electronic common technical documents, better known as eCTDs, came to the regulatory world more than ten years ago. In the past, the thought of changing the eCTD publishing tool was unthinkable, as the guidelines and specifications left little room for diversity and the systems did not work that well together. Also, there were only few vendors with proper tools.

Today, there are several eCTD publishing tool providers in the market, and their products vary in many aspects, such as in pricing, functionalities and sometimes even in information technical quality. However, even with the increased competition, the pricing has stayed quite high. For smaller companies, the annual costs might be significant, compared to the actual need for the tool. In such cases, the best option might be to outsource your eCTD publishing tasks to an external eCTD publishing service provider to save you valuable time and money.

As the lifecycles of eCTDs get longer, making their technical quality all the more important, changing the eCTD publisher might come into question. The change can have many benefits, from cutting costs to the better quality of the published eCTDs.

The actual change is not as demanding as one might think, as the current lifecycle can be continued with the new tool or with the new publisher from the next sequence, without any extra work for the authorities. At this point, baseline creation is not necessary, but on the other hand, the change provides a perfect opportunity to restructure the eCTD in case there is need for it.

We at Medfiles use an eCTD publishing tool that is widely used around the world by different authorities. With more than ten years of eCTD publishing experience, Medfiles can offer you experienced support for all your eCTD publishing needs, including working as your dedicated eCTD publishing service provider.

Contact Jesse Salonen, Head of Support Operations, if you need support with eCTDs jesse.salonen@medfiles.eu

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