eCTD Software and Tools

The electronic common technical document (eCTD), developed by the International Conference on Harmonisation (ICH), is now the standard format for the submission of electronic regulatory documents in the US, Canada, Europe, and Japan. The eCTD is an electronic organization of submission content into specific modules, sections, and documents via the use of an XML (extensible markup language) backbone. Essentially, this backbone structures the eCTD submission so that each document (or "leaf") resides in a ‘subfolder’ of a specified section, and each section in a ‘folder’ of its specified module.

eCTD is now the only acceptable format for the electronic submission of regulatory documents to the FDA (for both CDER and CBER). In the past few years, the FDA has begun to actively encourage sponsors that still submit paper applications to begin the process of transitioning to eCTD submissions. For most drug companies, this means that many significant changes need to be made and many new business processes need to be developed.

While both the FDA and ICH offer several guidance documents intended to facilitate the transition to eCTD submissions, these resources fail to address many important considerations:

• What eCTD regulatory software and tools will your company require, and which software provider(s) can offer a package that suits your needs?
• Which eCTD training courses are most effective for your esubmissions?
• Should you consider investing in eCTD Consulting or regulatory submission assistance?
• Would it be better to outsource your eCTD submissions or submission management to a Contract Research Organization (CRO)?

These questions can be very difficult to answer for somebody who has little experience with eCTD processes. eCTDsoftware.com was developed to help you answer the above questions.

Types of eCTD Software

Depending on the provider, a software package could include any combination of the following applications and tools for FDA eCTD submissions:

• Authoring Templates and Style Guides
• Regulatory Document (MS Word or PDF) Editor Tools
• Standardized Data Preparation Tools (SAAS, CDISC)
• Product Label Creation Tool (SPL/PLR)
• eSubmission Assembly, XML publishing, and Validation Tools
• eCTD Viewer

An entire suite of eCTD software and tools could easily set a company back hunderds of thousands of dollars. With the right advice and proper planning, however, a lot of money and implementation time can be salvaged by purchasing the right package for your company's unique eCTD requirements.