Enzyme is a software platform designed to help life science companies, particularly in medical device, diagnostic, and digital health sectors, automate and simplify FDA compliance and regulatory approval processes. It acts like TurboTax for FDA-regulated products, reducing the time and cost associated with bringing drugs and medical devices to market by replacing labor-intensive, paper-based workflows with an integrated electronic Quality Management System (eQMS). Enzyme supports compliance activities such as document control, design control, risk management, complaint handling, and CAPA, enabling existing teams to perform compliance work internally and reducing reliance on consultants or full-time compliance officers. The platform is hosted in private clouds for each customer to ensure compliance and data isolation, focusing initially on US FDA 510(k) products, with expertise across multiple geographies and regulatory strategies.
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10 months ago