eCTD Editor - Properties

The eCTD Editor enables to create a valid submission for pharmaceutical registration at the Regulatory Office, e.g. SÚKL, in accordance with the ICH M2 EWG specification and to update this submission as the preparation develops and its new variations are created.

The application respects current versions of relevant regulations, in particular the following ones:

Using the application is very simple.

The user environment has been designed with MS Silverlight. You can initialise it right from your favourite web browser or install it locally.

eCTD editor

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The application guides the user through the process of creating documentation starting from the initial step of writing the product’s name, first submission, creation or upload of complete documents, references to relevant documents from previous submissions, filling in required attributes, creating envelopes for submissions, modification and creation of new folders, etc. All types of registration procedures are supported: centralized, national, mutual-recognition, decentralised.

When creating a submission, the user is guided by the program to ensure that every single rule of the set consisting of some 700 rules formulating the requirements what the resulting documentation should look like are respected. That is why the validation process can result only in reminders saying that the user has omitted to do some task, not that the user has done some task incorrectly (!) The last phase of the program consists of exporting the submission into the folder from which the whole structure can be burnt on a CD or DVD.

Beside allowed types of files, the user can upload into the system also documents from MS Office. Conversion into the allowed format (PDF) is carried out automatically by the system.

The validity of generated submissions is verified by eCTD Editor. In addition to that, generated submissions can be further verified by any validator that can be chosen from a large number of validators available on the Internet.

Samples from the Program

Uploading a document into the application

Please notice that the dialogue advises the user what kind of information should be included in the document. This manual is a compilation from all published documents ICH M2 EWG.

eCTD editor

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The program automatically fixes names of folders so that they meet conditions prescribed by specifications. The name can be further edited. The program enables to upload only such files that can be converted into pdf or another allowed file format and that do not excess the allowed size.

eCTD editor

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While uploading files to subsequent submissions, the program offers other actions, not only “new” but also “append”, “replace”, “delete”. In such case you have to select also the previous version (that is being modified) of the document. The program offers only such versions that can be taken into account . You can open previous versions of documents by clicking on them in the roll-up.

eCTD editor

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Reasons for Purchase

prepinac Simplified Creation of a Submission

Specifications of the eCTD format include some 700 rules, which is a very complex definition. Creating a submission in the eCTD format without appropriate software is possible but extremely difficult. Moreover, it would require that the author knows all relevant rules that keep changing in time.

eCTD Editor radically simplifies creating a submission.

prepinac Certitude of the formal validity of a submission

Not only does eCTD Editor respect validation criteria (see EU eCTD Validation Criteria.pdf): it also guides its users when creating a submission in accordance with other rules from previous versions of particular format specifications that are not included in validation criteria. You can be certain that the generated submission is valid. Naturally, every new submission can be further validated with freeware validators.

prepinac Comfort of the state-of-the-art technologies

eCTD Editor guides users through the process of creation of each document. It includes all instructions that are available in documents in ICH M2 EWG and M1 EU concerning creation of electronic submissions. Users work in the environment of a web browser with comfort that they would expect with a locally installed application. It is because the application has been created in the most modern way, i.e. in the environment of Microsoft Silverlight.

Documents can be written in MS Word. With tools available in MS Office users can create references to other documents that are included in the documentation that is being created. Users can access the document depository in eCTD Editor like any other standard shared network disc so that they can work as they are used to. They do not need to extract the document out of the system in a complicated manner and then, after making changes, return it back and lose time.

prepinac Switch to different software without any extra costs

eCTD Editor focuses on one single thing. To help users create a valid eCTD submission and make it as easy as possible. It is not an extension of existing software for, e.g., document administration that would add complexity and services required for creating and administering eCTD submissions which, however, the user would have to master and then, naturally pay to the supplier.

Why Choose Us?

prepinac The cheapest complex solution

eCTD Editor is available in three editions, so every user can choose the edition that suits them best. When using “Starter”, which is the cheapest edition, users pay only per each use. The Single MAH edition enables common pharmaceutical companies to create as many submissions as they wish for one MAH. The licence of the Registrator edition makes it possible to create eCTD submissions for different MAHs and to do business offering services using eCTD Editor.

At present, eCTD EDitor is the cheapest complex software solution for eCTD submissions.

prepinac Support of future changes in specifications

Support also includes update of eCTD Editor in case the central regulatory authority issues a new version of specifications.

prepinac Assistance for you communication with authorities

Communicating with different authorities is time consuming. As a part of our support we also offer you our assistance when you try to get additional information from offices in the EU member states.

prepinac eCTD Assistant

It is a service offering to operate eCTD Editor instead of the user. All you need to do is to provide us with the documents and our eCTD Assistant will prepare the eCTD submission for you.

prepinac Cloud

Every edition of eCTD Editor can be run in the Cloud regime. You do not need to install anything. Running the program, backing-up data, connection to the network and continuous supervision is provided by our company.

Frequently Asked Questions

prepinac What criteria do uploaded documents need to meet?

eCTD Editor accepts only those types of documents that are allowed by the specifications. You can also work with documents from any version of MS Office. The advantage of this format is that while generating a new submission, eCTD Editor checks all the references included before converting them into pdf and in case the references are invalid, it fixes them, if possible. In some cases the MS Office format is required (see REG 84 version 1 SÚKL).

prepinac How is the sequence validity checked before a submission is filed?

To check the validity of xml files we use our own code or components from Microsoft. The criteria that cannot be rewritten using DTD or MS XML Schema are often checked when documents are uploaded. It is not possible to upload, e.g., a document with an invalid name, without mandatory xml attributes, etc.

prepinac What is the language in the environment of eCTD Editor?

eCTD Editor is a global application. It supports different cultures of work with dates, number formats, etc. It only requires writing from left to right, from the top downwards. It is translatable into any language. At present eCTD Editor is localised into English.