Predict your next investment

Enzyme company logo
INTERNET | Internet Software & Services / Compliance
enzyme.com

See what CB Insights has to offer

Stage

Seed VC | Alive

Total Raised

$120K

About Enzyme

Enzyme provides FDA compliance and quality systems as a service, coupling a cloud-based software solution with tailored support. Its first product is a quality management system tailor-made for medical device companies.

Enzyme Headquarter Location

611 Gateway Boulevard Suite 120

South San Francisco, California, 94080,

United States

Latest Enzyme News

Enzyme.com wants to make FDA compliance easier for startups

Jun 13, 2021

The Food and Drug Administration approval process can be like navigating a minefield for health startups hoping to get through regulations and begin selling to the American public. YC company Enzyme.com hopes to help these small businesses by automating the process for them. Biomedical engineer Jared Seehafer came up with the idea through his own experience consulting with health companies like Genentech. He found going through all the paperwork to get into compliance wasn’t just tedious but also a big part of what’s holding back small companies. “You find you spend almost as much time documenting the work as you do doing the work,” Seehafer told TechCrunch. “This is a multitrillion-dollar industry and I thought ‘why isn’t there software to automate the process?’ ” Compliance is the second biggest problem after raising capital for founders in the health space, according to Seehafer. So he rolled up his sleeves, brought in co-founder and regulations expert Jake Graham and launched Enzyme out of beta last summer to provide an automated software system companies can use to integrate with platforms like Jira, Trello and GitHub. Alternatives exist to help with compliance, but they often involve an expertise in the field and a hodgepodge of different software systems. With Enzyme, Seehafer says startups don’t need a background understanding in regulatory issues and don’t have to duplicate the paperwork, either. They can just plug it in and have it ready to go when the FDA comes knocking. So far Enzyme has raised $1.85 million from Refactor Capital, Data Collective, Soma Capital and Rock Health and various angels like Elizabeth Iorns from Science Exchange. The startup is currently working with about 10 companies, and Seehafer says he has an aggressive growth target for 2018, with a particular focus on targeting early funded digital health companies in need of this sort of service. He’s also going after partnerships with accelerators and VC firms to help him get in front of these companies. Of course, a company could go it on their own and try to follow guidelines placed on the FDA’s website . However, Seehafer says many end up hiring consultants, full-time compliance officers or spending exorbitant amounts of money to get them to the next phase, even with the guidelines clearly in place. “There are disincentives to making it clear [on how to get in compliance] and there’s different levels of approval for different stages,” he said. Seehafer hopes Enzyme helps founders not only navigate the process more smoothly but also educates the community so those with an idea can concentrate on innovating more and dealing with paperwork less. Would something like Enzyme have helped Theranos navigate the process? Seehafer laughed, adding the beleaguered blood testing company “didn’t follow FDA compliance 101.”

Predict your next investment

The CB Insights tech market intelligence platform analyzes millions of data points on venture capital, startups, patents , partnerships and news mentions to help you see tomorrow's opportunities, today.

Expert Collections containing Enzyme

Expert Collections are analyst-curated lists that highlight the companies you need to know in the most important technology spaces.

Enzyme is included in 2 Expert Collections, including Regtech.

R

Regtech

1,342 items

Technology that addresses regulatory challenges and facilitates the delivery of compliance requirements in FIs. Regulatory technology helps FIs and regulators address challenges ranging from traditional compliance and risk management to data reporting and transmission.

D

Digital Health

11,293 items

Technologies, platforms, and systems that engage consumers for lifestyle, wellness, or health-related purposes; capture, store, or transmit health data; and/or support life science and clinical operations. (DiME, DTA, HealthXL, & NODE.Health)

Enzyme Patents

Enzyme has filed 3 patents.

The 3 most popular patent topics include:

  • Amino acids
  • Computer network security
  • Disaccharides
patents chart

Application Date

Grant Date

Title

Related Topics

Status

11/27/2018

5/18/2021

Disaccharides, Sugar substitutes, Amino acids, Metabolism, Monoamine oxidase inhibitors

Grant

00/00/0000

00/00/0000

Subscribe to see more

Subscribe to see more

Subscribe to see more

00/00/0000

00/00/0000

Subscribe to see more

Subscribe to see more

Subscribe to see more

Application Date

11/27/2018

00/00/0000

00/00/0000

Grant Date

5/18/2021

00/00/0000

00/00/0000

Title

Subscribe to see more

Subscribe to see more

Related Topics

Disaccharides, Sugar substitutes, Amino acids, Metabolism, Monoamine oxidase inhibitors

Subscribe to see more

Subscribe to see more

Status

Grant

Subscribe to see more

Subscribe to see more

Enzyme Web Traffic

Rank
Page Views per User (PVPU)
Page Views per Million (PVPM)
Reach per Million (RPM)
CBI Logo

Enzyme Rank

CB Insights uses Cookies

CBI websites generally use certain cookies to enable better interactions with our sites and services. Use of these cookies, which may be stored on your device, permits us to improve and customize your experience. You can read more about your cookie choices at our privacy policy here. By continuing to use this site you are consenting to these choices.