Creating documents for an eCTD application is time consuming and involves numerous authors, resulting in document formatting inconsistencies and a lengthy review and approval process. The ONIX eCTD Microsoft Word templates streamline the process by providing a standard structure.

What is a common technical document?

The ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) created the common technical document (CTD) to provide a format for marketing authorisation submissions in all relevant sectors. They also developed the regulatory electronic submission standard Electronic Common Technical Document (eCTD) that has been adopted in many countries, including the US, Canada and Japan.

The adoption of the eCTD format has been welcomed, as it has many benefits to drug development companies, including:

  • clarity around document status
  • document re-use without resubmission of data
  • ease of navigation
  • reduction in document storage

What is an eCTD dossier?

The eCTD dossier is a collection of data, files and information required by a regulatory body to be included in an eCTD submission. In the US, eCTD dossiers are called new drug applications (NDA), and in the European Union and other countries, they are known as marketing authorisation applications (MAA).

When companies create dossiers for new products.,  the document structure needs to be consistent But, the content is specific to the drug application  – having a CTD template with predefined numbered headings, document headers and footers, tables, and cross-references – eases the burden of formatting for the writers.

ONIX has an excellent track record of supporting clients with their drug applications and has worked hard to ensure none of their clients' documents is duplicated. This is why we have created the MS Word eCTD template to help us ensure the accuracy, consistency and reusability of all documents across dossiers.

What do ONIX MS Word eCTD templates include?

The ONIX MS Word eCTD templates provide a common structure with an easy-to-use ONIX toolbar to standardise the formatting in a one-click approach, resulting in consistently formatted documents which are easy to review, saving you time and resources.

Our eCTD template suite includes the following:

  • Granular module 1 to 5 templates
  • Pre-populated metadata
  • Pre-defined headings with eCTD numbering
  • Tables with eCTD numbering
  • Headers and footers implemented for portrait and landscape pages

The templates can reduce rework and speed up approvals as the associated toolbar allows you to standardise the format in a one-click approach for tasks such as:

  • Applying commonly used styles
  • Batch update on metadata across all relevant documents
  • Copying and pasting text from other sources in the correct format
  • Creation of tables
  • Generation of tables of contents
  • Insertion of cross-references
  • Switching page orientation to retain headers and footers

Developed to drive eSubmission efficiency, our eCTD Word templates streamline your submission process by removing any uncertainties and lengthy approval processes.

Implementing the ONIX eCTD Microsoft Word templates streamlines the process by providing a common structure with an easy-to-use ONIX toolbar to standardise the formatting in a one-click approach, saving you time and resources.

For more information, please get in touch with our expert team.