EnzymeEnzyme Consulting

Enzyme Consulting provides in-house experts with over a decade of experience across design assurance, systems engineering, quality and quality system setup and remediation, clinical trial design, and specialty engineering support for regulated product teams.

The practice also covers regulatory strategy, 510(k), PMA, and combination submissions, plus representation before FDA and notified bodies. Delivery is flexible through time-and-materials, project-based, retainer, or embedded models for startups through large enterprises, inside or outside the Enzyme eQMS.