Guidance for Industry on Providing Regulatory Information in Electronic Format. Harmonised Technical Guidance for. eCTD Submissions in the EU. Version eCTDmanager enables you to build, view, validate and publish compliant submissions based on eCTD, NeeS, eCopy, IMPD, CTA, VNeeS, DMF, ASMF and. Challenges of eCTD Collecting documents/data from study sites Case Report Forms Cost/time to convert to compliant electronic format.

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Purchasing a new EXTEDO application is the first step compilant streamlining business and regulatory processes within your organization. This is a big transition for China to move from paper submission to eCTD submissions [12].

To ensure you get the most out of your purchased solution, we offer detailed training for each product ect the EXTEDOsuite solution portfolio. The need to build, view, validate and publish eSubmissions based on standardized submission formats comes with its own set of challenges.

Its intuitive interface enables you to easily handle electronic submissions without prior knowledge of XML-technology, and its unique visual aids provide context, ensuring simplified completion complkant unprecedented accuracy. How did you hear about us? Retrieved from ” https: By using this site, you agree to the Terms of Use and Privacy Policy.

eCTD Publishing & eSubmission Software EXTEDO eCTDmanager

The eCTD is a message specification for the transfer of files and metadata from a submitter to a receiver. Retrieved 13 August Contact me I would like to receive e-mails e.


They must be placed in the directory:. Food and Drug Administration. Impressum Legal Disclaimer Privacy Policy. From Wikipedia, the free encyclopedia. Reducing the expense of managing compliant electronic submissions The effective management of validated and compliant eSubmissions is a complex process.

Stylesheets that support the presentation and navigation should be included. You can revoke your consent at any time for the future by sending an e-mail to info extedo. With the high costs associated preparing regulatory submissions it is essential that the compilation and publishing processes are fully optimized.

On May 5,the U. Learn more about our training offerings. Read the related customer success story. A full table of contents could be quite large. In order to maximize profitability, modern pharmaceutical organizations need to be able to register products as quickly as possible whilst ensuring compliance with a variety of global regulations. However, ensuring correct installation, implementation and integration is a crucial step in the process of deploying your new solution.

eCTDmanager – eCTD Management Software Solution

Retrieved 29 October Don’t fill this field! Regulatory Affairs Professionals Society. This page was last edited on 7 Julyat Its scalable, all-in-one submission management capabilities meet the requirements for both electronic like eCTD and paper submissions.

I am interested in. Clinical ecttd Clinical data management Health informatics Health standards. Available both as an in-house or hosted dctd, eCTDmanager enables your organization to be prepared for upcoming regulatory and technical changes, like the introduction of future standards such as eCTD 4. Life Sciences Regulatory Technology.

Electronic common technical document

In addition, managing submissions ectx multiple regions also requires that all submissions must be compliant with the ICH and regional specifications, which further complicates the overall process. This is the file index. The electronic common technical document eCTD is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information.


Director, Regulatory Informatics and Submission Management at a top 30 pharma company. To dctd compliance, you need an eCTD software solution that enables you to maintain a comprehensive overview of your submission statuses across a number of products within multiple different geographic markets.

Yes, it’s still alive”.

Detailed information on handling user data can be found in our Privacy Policy https: Each submission message constitutes one “sequence”. It also provides you with a complete regulatory dossier assembly environment that enables your organization to operate in a compliant manner within a heavily regulated environment. The effective management of validated and compliant eSubmissions is a complex process. Articles containing potentially complisnt statements from August All articles containing potentially dated statements.

The CTD defines the content only of the common modules. A Draft Implementation Guide for version 4. Click here for more details.

Views Read Edit View history. As the trusted validator used by more than 35 regulatory authorities, eCTDmanager goes beyond basic eCTD submissions software.

The most comprehensive eCTD management software solution eCTDmanager provides you with a complete regulatory dossier management and assembly solution.