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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To ensure 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.

Food and Drug Administration.

However, ensuring correct installation, implementation and integration is a crucial step in the process of deploying your new solution. Life Sciences Regulatory Technology.

eCTDmanager – eCTD Management Software Solution

Detailed information on handling user data can be found in our Privacy Policy https: Articles containing potentially dated statements from August All articles containing potentially dated statements. Read the related customer success story. A Draft Implementation Guide for version 4. Stylesheets that support the presentation and navigation should be included. The need to build, view, validate and publish eSubmissions based on standardized submission formats comes with its own set of challenges.

They must be placed in the directory:. Regulatory Affairs Professionals Society. A cumulative eCTD consists of one or more sequences. Yes, it’s still alive”.

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. Learn more about complian training offerings. Available copliant as an in-house or hosted solution, eCTDmanager enables your organization to be prepared for upcoming regulatory and technical changes, like the introduction of future standards such as eCTD 4.


Each submission message constitutes one “sequence”. The most comprehensive eCTD management software solution eCTDmanager provides you with a complete regulatory dossier management and assembly solution. With the high costs associated preparing regulatory submissions it is essential that the compilation and publishing processes are fully optimized. The primary technical components are:.

Purchasing a new EXTEDO application is the first step to streamlining business and regulatory processes within your organization. The eCTD is a message specification for the transfer of files and metadata from a submitter to a receiver. The effective management of validated and compliant eSubmissions is a complex process.

In addition, managing submissions in multiple regions also requires that all submissions must be compliant with the ICH and regional specifications, which further complicates the overall process. We were working on compiling dossiers almost immediately after the installation. To ensure you get the most out of your purchased solution, we offer detailed training for each product within the EXTEDOsuite solution portfolio.

The CTD defines the content only of the common modules. Reducing the expense of managing compliant electronic submissions The effective management of validated and compliant eSubmissions is a complex process. On May 5,the U. Contact me I would like to receive e-mails e.

As the trusted validator used by more than 35 regulatory authorities, eCTDmanager goes beyond basic eCTD submissions software. Retrieved 29 October Impressum Legal Disclaimer Privacy Policy. 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.


eCTD Publishing & eSubmission Software EXTEDO eCTDmanager

Retrieved from ” https: How did you hear about us? A full table of contents could be quite large. I am interested in. By using this site, you agree to the Terms ectv Use and Privacy Policy.

Preparing Compliant eCTD Submissions – RAPS Regulatory Exchange

Its scalable, all-in-one submission management capabilities meet the requirements for both electronic like eCTD and paper submissions. Director, Regulatory Informatics and Submission Management at a top 30 pharma company. This page was last edited on 7 Julyat Views Read Edit View history. From Wikipedia, the free encyclopedia. Click here for more details.

Training sessions are tailored to your individual needs and cover a broad range of technical and regulatory topics. You can revoke your consent at any time for the future by sending an e-mail to info extedo. Retrieved 13 August Clinical research Clinical data management Health informatics Health standards.

The electronic common technical document eCTD is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information.

Dompliant is the file index. 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 and unprecedented accuracy.