But there is a growing divide between what is needed to produce the submitted documents and what is required when filing an electronic submission.

The industry is increasingly adopting the electronic common technical document (eCTD) format for submissions. eCTD allows documents to be broken down into small "chunks," so whenever there is a change, only the changes are sent — not the entire revised document. Unfortunately, this approach doesn't fit into the traditional way in which documents are managed — at least not yet.

What's needed is something called component-based content management, according to Tom Moore, practice manager for pharmaceutical document management at the consultancy Intrasphere. With component-based content management, the chunks of a document, rather than the entire document, are stored in a repository. "You break documents into components," Moore says. "Each component can have separate properties such as a life cycle for each [element]." In this way, each element could be separately edited and reused.

Many experts believe XML is ideally suited to being the underlying technology for component-based content management. Document management systems could easily manage the storage of the components in XML format and enforce the workflow requirements needed to ensure that each component is handled properly.

But there's a catch. "When authoring documents for submissions, [people] like to deal with the documents holistically," Moore says. "You don't want to edit everything at the component level; you want to edit at the document level."

What's missing is a wide selection of XML authoring and editing tools. Moore notes that there are several on the market today, though he declined to endorse any specifically. But many people are looking to Microsoft's efforts to support XML.

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