eCTD Submission Manager

The eCTD Submission Manager aims to simplify the job of creating, managing and reviewing submissions. It is the duty of every pharmaceutical company to ensure the effective management of their electronic Common Technical Document (eCTD) submissions.

Our eCTD Submissin Manager software is dedicated to small or mid-size companies who need simple and fast way of eCTD submissions preparations.

Efficiency and simplicity

Our eCTD submission software comes with step-by-step instruction wizards that will take the user through the entire process, easily. With this, costly errors are eliminated, training requirements are minimised and learning curves are reduced. We also allow data import from various sources and complete them by bookmarking the documents and hyperlinking them.

Least price, superior performance

To minimise the disruption to already existing IT infrastructure and to reduce costs, the software works on a centralised platform that is accessible through the desktop. Multiregional and global deployments are easy and less expensive than other traditional applications. There are absolutely no installation and maintenance costs involved. The installation footprint is minimised and so is the complexity due to the use of standardised architectures.

Global functionality

The adoption of eCTDs by the local health authorities present in the region is easy as the users can collaborate with the local companies to develop core dossiers that are simple and reusable. Global level data is managed while providing full functionality. The software also supports multiple languages and comes with performance upgrades.

Simply conversion tool

Our customers who worked with NeeS before love it. Why? Because as you have your files in NeeS folder structure already, you do not need anything more with the data. You just run our eCTD Submissin Manager on your folder structure, that is it. There is no need to upload the files anywhere or set some additional parameters. Once you plan switch from NeeS to eCTD, our solution will save a lot of your time.

Security

The eCTD Manager works only with your data in NeeS/eCTD folder structure. There is no additional database, extra file repository or any kind of data integration. You just point eCTD Manager to your folder structure, it will validate your submission and create mandatory eCTD files as per the specification.