The preparation of the electronic Common Technical Document (eCTD) format

The preparation of the electronic Common Technical Document (eCTD) format for drug registration requires pharmaceutical companies to transition from paper-based documentation to digital management, review established business processes, and reformat existing regulatory dossiers to comply with the new electronic standard.

This transition leads to an increase in the number of files that make up the electronic regulatory dossier. There is a need to store thousands of documents in PDF and DOC formats, which are required for convenient text editing. However, this complicates their updating, tracking, and timely management of modifications. As a result, the risk of using outdated or unverified files increases, as does the likelihood of errors when incorporating documents into the dossier.

To solve this problem, the eCTD-Base Document File Repository has been developed. It provides centralized storage, efficient management, and control of the relevance of eCTD documents, significantly optimizing the preparation of regulatory materials.

The main features and characteristics are as follows:

• Storing document files in DOC and PDF formats.
• Monitoring the relevance of document files during their use.
• Managing document changes, maintaining a history of document changes.
• Supporting collective preparation of documents by different departments of a pharmaceutical company.
• Converting document files from DOC format to PDF format.
• Full-text search for documents.
• Uploading (importing) document files to the repository from external file storages.
• Performing a comparative analysis of document versions and searching for changes.
• Uploading a package of files to the electronic registration dossier (submission).

The software is now available for ordering and integration. Our specialists provide a full range of services for training, technical support and system customization to individual customer needs.

You can find more detailed information on the eCTD-Base page of our website or by contacting us.

The launch of the new software opens up new opportunities for pharmaceutical companies, simplifying regulatory processes and increasing efficiency. We are confident that our product will become a reliable tool in your work!