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Aquila Solutions LLC

Template Creation Process

Aquila commits to providing and maintaining superior CTD templates.  When we determine the need for a new template we begin a process than may take several months.  This may be triggered by changes in the publishing regulations, new standards (like RPS) or user requests.

General Template Development Steps:

  1. Research the details of the template content.  We typically use FDA, EMA, Health Canada, ICH and some industry documentation.
  2. Identify the requirements for the Template and create a draft template.  This includes content, guidance text as well as possible granularity levels.
  3. Determine the Template Title, file name and eCTD location.  This allows the sponsor to easily use the new template without having to worry about renaming the document.
  4. Create a short description of the contents of the document.  This is used to provide a quick explanation of the template prior to customization.
  5. Determine the filter options.  This populates the filter menus which allows sponsors to easily locate all appropriate templates for a specific application type.
  6. Integrate the new template into eCTD Accelerator – Templates as a BETA template.  Sponsors may elect to try out our new or updated templates by optin into our Beta system through the information page.
  7. After detailed review by our beta testers the new template is finalized and added to the available template list.  It will be available the next time you open the desktop control software.

Aquila also commits to constant improvement of our existing templates.  All templates are reviewed periodically.  We will update the template to improve clarity, structure, spelling/grammar as well as technological / efficiency updates.

 

If you would like to request a CTD or eCTD template please fill out our Request Form.

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