Options For Ectd Publishing Tools & The Submission Process Service

By Author: Justin Finch
Total Articles: 12
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Most countries are implementing eCTD Publishing Service and this could be the reason for the companies to make decisions regarding the way they are going to manage the electronic submission and the use of eCTD Publishing Tools.

Our companies mainly look after 3 major services which include-

• Companies that have already outsourced the eCTD entirely
• Companies that have maintained control of the electronic eCTD Publishing Service both at the corporate and the head office level
• Other companies who have retained the day-to-day eCTD maintenance and the lifecycle at the local level

Options for the eCTD publishing & the Submission Service

Companies That Maintain Control of Electronic Publishing at the Head Office Level

For these corporate companies challenges can be observed with the streamlining process & also be adjusting the procedures for the collection of the several national requirements for the eCTD submission.

As per some sources, big adjustments are being conducted from the past processes and in ...
... this, the core dossier documentation is filtered out to the local partners. After that, the final submission is done at a national level.

Companies That Have Outsourced the eCTD Viewer Totally

For several reasons, most of the other companies have outsourced their eCTD publishing. Most companies especially those smaller companies are not interested in investing in that newly developed eCTD software and the intensive extensive training which the staff must undertake so that they can best utilize this software.

Some of the other companies rather simply choose to channel their energy and efforts to those commercial efforts, and that’s why they outsource their eCTD publishing to third-party providers.

Companies that Retained the Day-to-Day Maintenance of the eCTD Publishing Tools and Lifecycle at a Local Level

First of all, it's very much costly for retaining the eCTD maintenance and the lifecycle at a local level. We know that at the local level, there might be all the national documentation requirements and there can be a regulatory history behind the marketing authorization.

But you may find that the cost involved for the training on this eCTD software and also for the issuing of this eCTD Publishing Service license along with the eCTD viewer to each of the local partners is very much costly.

It’s very hard to maintain the company-wide eCTD dossier & structure format when the different local partners are working in the isolation.

Supports Which We Can Provide With the Electronic Publishing

In-licensing the eCTD dossiers

We can assist you in providing valuable insight into what kind of state the eCTD dossier is in and will try to provide you guidance on the way to proceed with the eCTD structural problems.

Support Capabilities

We try to provide an array of services that will cover many challenges that are faced with global eCTD publishing. We are mainly available in all the GMT zones. We are eagerly there for you and will love to serve as a backup submission that needs to be published and submitted urgently.

Conversion of Dossiers to the eCTD

We will gladly be helping you with the conversion of the NeeS or the paper dossier to the eCTD for the baseline submissions.