Enzyme

Enzyme

Software-Development

South San Francisco,...
United States
Company Tagline

A QMS as innovative as you

Industry Category
Software-Development
Company Description

Enzyme is dedicated to automating and simplifying regulatory approval and compliance processes within the life science sector. Enzyme aims to reduce the cost of compliance and expedite the market launch of cutting-edge technologies. The company’s cloud-based Quality Management System (QMS) streamlines documentation and integrates seamlessly with existing tools. Enzyme's experts provide guidance throughout the entire regulatory and compliance lifecycle, from pre-submission to product design and development, regulatory submission, and post-market compliance.

Enzyme supports all life science companies, with a particular focus on those developing digital health solutions and software as a medical device (SaMD) products. Located at 611 Gateway Blvd, Suite 120, South San Francisco, California 94080, US, Enzyme offers innovative solutions designed to meet the evolving needs of the industry.

Enzyme is committed to innovation and excellence in the life sciences. We invite the management team at Enzyme to create a customized and exclusive company showcase and product listing on our platform to further enhance your commercial development.

Enzyme se consacre à l'automatisation et à la simplification des processus d'approbation réglementaire et de conformité dans le secteur des sciences de la vie. Enzyme vise à réduire le coût de la conformité et à accélérer la mise sur le marché des technologies de pointe. Le système de gestion de la qualité (QMS) basé sur le cloud de l'entreprise rationalise la documentation et s'intègre de manière transparente aux outils existants. Les experts d'Enzyme fournissent des conseils tout au long du cycle de vie réglementaire et de conformité, de la pré-soumission à la conception et au développement des produits, en passant par la soumission réglementaire et la conformité post-commercialisation.

Enzyme soutient toutes les entreprises des sciences de la vie, avec un accent particulier sur celles qui développent des solutions de santé numérique et des logiciels en tant que dispositifs médicaux (SaMD). Située au 611 Gateway Blvd, Suite 120, South San Francisco, California 94080, US, Enzyme propose des solutions innovantes conçues pour répondre aux besoins en constante évolution de l'industrie.

Enzyme s'engage en faveur de l'innovation et de l'excellence dans le domaine des sciences de la vie. Nous invitons l'équipe de direction d'Enzyme à créer une vitrine d'entreprise et une liste de produits personnalisées et exclusives sur notre plateforme afin d'améliorer encore votre développement commercial.

Key Personnel / Employees
RAJAVEL P G Samuel Haro Joshua Pham Rowena Bozcaada

Compare Companies Side by Side

Compare Enzyme with 3 companies in Software-Development

4 Companies
Comparison Field
Enzyme
Enzyme
Main Company
Axendia, Inc.
Axendia, Inc.
View Profile
MEDIcept Inc.
MEDIcept Inc.
View Profile
Fang Consulting
Fang Consulting
View Profile
Founded Year
2005 1996 1999
Company Size
2-10 11-50 11-50
City
South San Francisco, California Yardley, PA Boston, MA Roseville, MN
Country
United States United States United States United States
Skills & Keywords Comparing with main company
14 Total Skills
Life Science Regulatory Approval Compliance Automation Quality Management System Digital Health Solutions SaMD Products Medical Device Software Regulatory Submission Regulatory SaMD Medical Device digital health 510(k) FDA QMS
12 Total 12 Unique
Unique Skills:
Advice Business Consulting Ergonomics Food Healthcare +6
25 Total 25 Unique
Unique Skills:
483 / Warning Letter Audits CAPA Clinical Clinical Research Organization CRO +19
16 Total 16 Unique
Unique Skills:
21 CFR CE Mark Class I Design Dossier Preparation HIPAA Compliant II +10
4
Total Companies
1996
Oldest Founded
1
Countries
66
Unique Skills

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Alternative Company Names

This company is also known as

Enzyme एन्जाइम Enzima إنزيم Фермент