Enzyme is a software platform that automates and simplifies regulatory approval and compliance processes for life science companies. Their core offering is a cloud-based Quality Management System (QMS) designed to reduce the cost of compliance and speed up the path to market for innovative medical and digital health technologies.
Enzyme’s QMS streamlines documentation and integrates with tools commonly used by life science organizations. The platform supports the entire regulatory and compliance lifecycle, including pre-submission, product design and development, regulatory submissions, and post-market compliance activities. In addition to the software, Enzyme provides expert guidance throughout these stages, helping clients navigate complex regulatory requirements more efficiently.
Who Uses Enzyme?
Enzyme primarily serves companies in the life sciences sector, with a particular focus on those developing digital health products and Software as a Medical Device (SaMD). Their client base includes a range of startups and established enterprises, such as:
- Pfizer
- Roche
- Stryker
- Genentech
- Avails Medical
- Click Therapeutics
- The Flex Company
- Akyrian
- CARI Health
- Cateva Solutions
- ClearCam
- Emboline
- Empo Health
- Evidation
- Hannah Life Technologies
- Innovate Calgary
- Limbix
- Lokavant
- NeuraStatis
- Npower
- Overjet
- Sebela
- Spire Health
- Vaxess
- GeneWEAVE
- Endpoint Health
- Subtle Medical
- DawnLight Technologies
How Was Enzyme Started?
Enzyme was founded by a team with deep expertise in regulatory affairs, quality management, software development, and customer success. Key members include Jared Seehafer (CEO & Co-Founder, RAC) and Jacob Graham (Co-Founder, CMDA, RAC), supported by a leadership group with backgrounds in operations, compliance, finance, and technology. Their collective experience informs Enzyme’s approach to automating compliance processes for the life sciences sector. More about their team can be found on their About page.
What Makes Enzyme Different?
Enzyme differentiates itself by combining a highly integrative cloud-based QMS with hands-on regulatory and compliance expertise. This blend allows clients not only to manage documentation and processes more efficiently, but also to receive personalized guidance throughout their product’s regulatory journey. The company’s emphasis on digital health and SaMD positions it well for supporting organizations working at the intersection of healthcare and software innovation.
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