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XML and Regulatory Formatting

XML Standards

XML is used by the FDA for labels, by software developers for a myriad of things, and by publishers to format long and short form materials for indexing as well as certain types of printing. We’ve been working with various XML standards since the mid-1990s. In 2020, we completed an XML formatting project for a pharmaceutical manufacturer. They needed a fully-validated XML file for their FDA submission. We provided the file and the source materials to ensure that any content changes would not affect the validated XML structure.

Regulatory Formatting

Regulatory formatting includes XML formatting. It also includes the various structures used for regulated documents and submittals. There are required sections and particular areas that must be addressed, even if it is to indicate that the business is exempt from that requirement. Proposals, RFP responses, Controlled Forms, and many other types of files all frequently have formatting requirements that go well beyond which font to use. In 2021, we proofread several Material Safety Data Sheets for a chemical manufacturer and spotted several issues that could have created confusion. Not something wanted on MSDS.

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