regulatory ectd

regulatory ectd common-technical-document

CTD - Common Technical Document

The Common Technical Document (CTD) must now be Electronic for Easy Accessibility in an Enterprise

The common technical document (often abbreviated as CTD) was developed by the ICH (International Conference on Harmonization) working group with representatives from regulatory bodies in Europe, Japan and the United States. The CTD is a set of specifications for the submission of regulatory data in the application for the right to market pharmaceuticals. The format of the common technical document is not to be confused with its content or submission type; rather, it is the means by which information in a submission is organized. The eCTD (electronic CTD) is the fully electronic application message which is most commonly used for regulatory submissions.

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Federal Mandate for CTD

The common technical document, which for years has been the means by which life sciences companies submitted regulatory materials to the U.S. Food and Drug Administration (FDA), must now (as of January 1, 2008) be submitted in electronic format (eCTD).

How MasterControl Common Technical Document Software Can Help Companies Meet Federal Requirements

MasterControl offers submissions software solutions that help life sciences companies efficiently and effectively prepare their regulatory submissions. MasterControl's enhanced Submissions Gateway and Submissions Locker software solutions, facilitate the proper preparation and submission of all documentation relating to a common technical document.

With MasterControl, common techinical documents may be maintained in the same format in which they must be distributed to the FDA. The individual documents that make up the common technical document can be effectively managed and kept secure throughout the document lifecycle. The unified MasterControl system controls access to documentation pertinent to the common technical document by providing a secure, centralized repository for storing and managing documentation.

The MasterControl solution controls CTD submissions documentation before, during and after publishing. This ensures that all participants involved in compiling the common technical document can have confidence that they are working with the most up-to-date, approved version of all document.

  • Submissions Ready Docs: MasterControl provides submission-related document templates, as well as preconfigured CTD document types specific to a company's submission. Collaboration functionality and MS-Word integration enable cross functional teams to collaborate on submissions documents, while ensuring their reliability and security.
  • Common Technical Document Approval: Copies of all documents approved within the MasterControl system are automatically sent to the Submissions Locker.
  • Common Technical Document Revision: If one of the documents contained in the common technical document is revised, an updated version is immediately exported to the Submissions Locker.

For More Information on CTD - Common Technical Document

For more information about how MasterControl can help with the assembly of the common technical document (CTD), please feel free to contact a MasterControl representative.

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