Enzyme is automating FDA compliance and approval for companies at the intersection of software and medicine.

Enzyme develops software that automates regulatory compliance tasks for life science companies. Their software platform replaces tens of thousands of documents and spreadsheets that are required to track and manage a company’s FDA approval process, saving companies hundreds of thousands in consulting and legal fees. Instead of forcing teams to manually draft documentation, Enzyme generates it programmatically by walking product teams through customized workflows and integrating with existing software tools such as JIRA and GitHub. Since launching in late 2017, Enzyme has grown to ten enterprise customers in the medical device and diagnostic spaces.

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