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Our consulting services are tailored to your needs. We can help you anywhere from streamlining your quality process to submission and post-market compliance.
CEO & Cofounder
VP QA/RA & Cofounder
Guidance for your entire regulatory and compliance lifecycle
Work with our trusted team of regulatory experts to write your submissions
Our team can help you prepare for audits and make sure you are ready
Quality at your fingertips
Our experts are can help you with all your quality needs such as internal audits and targeted training
We can walk you through the SOP’s and help you integrate them with Enzyme’s QMS
We are dedicated to your success
Our in-house experts have worked with a range of product device classes including SaMD, handled several remediations, conducted audits and successful submission and have led in-house compliance and regulatory teams. We are committed to empowering your team and getting your product to market faster.