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 you get the most out of your purchased solution, we offer detailed training for each product within the EXTEDOsuite solution portfolio. From Wikipedia, the free encyclopedia.

Impressum Legal Disclaimer Privacy Policy. Retrieved 13 August Director, Regulatory Informatics and Submission Management at a top 30 pharma company. You can revoke your consent at any time for the future by sending an e-mail compliiant info extedo.

Preparing Compliant eCTD Submissions

The need to build, view, validate and publish eSubmissions based on standardized submission formats comes with its own set of challenges. Articles containing potentially dated statements from August All articles containing potentially dated statements.

A Draft Implementation Guide for version 4. Stylesheets that support the presentation and navigation should be included. We were working on compiling dossiers almost immediately after the installation.


I am interested in. Its scalable, all-in-one submission management capabilities meet the requirements for both electronic like eCTD and paper submissions. Food and Drug Administration. Reducing the expense of managing compliant electronic submissions The effective management of validated and compliant eSubmissions is a complex process.

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

The primary technical components are:. A cumulative eCTD consists of one or more sequences. Each submission message constitutes one “sequence”. Detailed information on handling user data can be found in compliannt Privacy Policy https: Regulatory Affairs Professionals Society.

Preparing Compliant eCTD Submissions – RAPS Regulatory Exchange

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. Clinical research Clinical data management Health informatics Health standards.

Retrieved from ” https: Read the related customer success story. This is the file index.


The eCTD is a message specification for the transfer of files and metadata from a submitter to a receiver. Life Sciences Regulatory Technology. Click here for more cokpliant. Retrieved 29 October However, ensuring correct installation, implementation and integration is a crucial step in the process of deploying your new solution.

With the high costs associated preparing regulatory submissions it is essential that the compilation and publishing processes are fully optimized.

Training sessions are tailored to your individual needs and cover a broad range of technical and regulatory topics. It also provides you with a complete regulatory dossier assembly environment compliqnt 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. On May 5,the U. In order to maximize compliaht, modern pharmaceutical organizations need to be able to register products as quickly as possible whilst ensuring compliance with a variety of global regulations.