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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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. Stylesheets that support the presentation and navigation should be included.
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.
As the trusted validator used by more than 35 regulatory authorities, eCTDmanager goes beyond basic eCTD submissions software. To ensure you get the most out of your purchased solution, we offer detailed training for each product within the EXTEDOsuite solution portfolio. Available both 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. The electronic common technical document eCTD is an interface and international specification for the pharmaceutical industry to agency transfer of regulatory information.
Regulatory Affairs Professionals Society. Retrieved from ” https: The eCTD is a message specification for the transfer of files and metadata from a submitter to a receiver. The most comprehensive eCTD management software solution eCTDmanager provides you with a complete regulatory dossier management and assembly solution. The need to build, view, validate and publish eSubmissions based on standardized submission formats comes with its own set of challenges.
Its scalable, all-in-one submission management capabilities meet the requirements for both electronic like eCTD and comlpiant submissions.
Electronic common technical document
A Draft Implementation Guide for version 4. Articles containing potentially dated statements from August All articles containing potentially dated statements.
Learn more about our training offerings. The CTD defines the content only of the common modules. Click here for more details. On May 5,the U. Director, Regulatory Informatics and Submission Management at a top 30 pharma company. 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.
Each submission message constitutes one “sequence”. Contact me I would like to receive e-mails e.
Preparing Compliant eCTD Submissions
eCTD Publishing & eSubmission Software EXTEDO eCTDmanager
We were working on compiling dossiers almost immediately after the installation. 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. This is the file index. Purchasing a new EXTEDO application is the first step to streamlining business and regulatory processes within your organization.
Food and Drug Administration. 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. A full table of contents could be quite large. However, ensuring correct installation, implementation and integration is a crucial step in the process of deploying your new solution.
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. This is a big transition for China to move from paper submission to eCTD submissions .
Life Sciences Regulatory Technology. You can revoke your consent at any time for the future by sending an e-mail to info extedo.
Clinical research Clinical data management Health informatics Health standards. A cumulative eCTD consists of one or more sequences.
Read the related customer success story. From Wikipedia, the free encyclopedia. The primary technical components are:. Views Read Edit View history.