The FDA offers assistance to small businesses that plan to provide a submission using the eCTD specifications. The FDA recommends that you follow these steps to help simplify the process:

• Review the published guidance and specifications documents provided on the eCTD Web site, located under the Resources tab.
  
• Submit an eCTD sample prior to submitting an actual eCTD submission.
  
• Refer to the Comprehensive Table of Contents Headings and Hierarchy on the eCTD Web site, a link to which is located under the Resources tab.

Let's look at each of these steps in more detail.