Our consulting services are tailored to your needs. We can help you anywhere from streamlining your quality process to submission and post-market compliance.
Enzyme is your development, quality, and regulatory partner
- Enzyme’s mission is to empower life sciences companies to innovate better and faster
- Our experts support life sciences companies in navigating the path of compliance and ensuring program success
- We support the development and commercialization of digital, drug-device combination, software/hardware, diagnostic, and disposable healthcare products
Enzyme works with you
- We can integrate with your team or work independently and autonomously
- We offer flexible work packages to address your needs, from time-and-materials, to project-based, retainer, or embedded resource
- We work globally - Enzyme Consulting integrates with international clients and global teams
- We understand the needs of companies of all sizes, from 2-person startups, to Fortune 500 enterprises, and we understand how those needs differ
- We provide service to clients inside or outside the Enzyme eQMS - our team are experts at navigating complex and diverse quality systems
Leadership
with experience
Over 50 years of industry experience in compliance, cybersecurity, and product development, from Class I MDSS to Class III implantables and biopharma.
Jared Seehafer
Principal
Jacob Graham
Principal
Brian Intoccia
Managing Director
Development, engineering, and quality services
- Design assurance: We ensure proper verification and validation of your product prior to design transfer and submission, reducing risk of rework and project churn
- Systems engineering: We have adapted the key principles of systems engineering to the regulated medical environment enabling high quality design control and risk management deliverables, specializing in SaMD, Combination and Disposable devices
- Quality and quality systems: Quality systems setup from scratch and optimizing existing systems, assisting with audit preparation and defense, and running remediation projects
- Clinical trial design and specialty engineering: Specialty engineering and technical services, software, biomedical & mechanical engineering, and biostatistics
Regulatory services
- Regulatory strategy: From FDA engagement strategies to optimizing system architecture to streamlining approval processes, our regulatory expertise ensures your success
- Submission and engagement: The Enzyme team supports 510K, PMA, & combination product/device constituent for the US market and engagement with notified bodies
- History of success: We have managed the regulatory workstream to obtain multiple investigational device exemptions (IDE), multiple 510K clearances, and multiple drug-device combination product approvals (BLA/NDA)