A word on COVID-19 from the Enzyme Team
Dear Enzyme Friends & Customers,
As the world reacts to the universal and profound nature of COVID-19, the Enzyme team wants to offer our support to those on the frontlines trying to tackle the problem, and those elsewhere in the healthcare industry that are trying to deal with keeping their businesses running and their products shipping.
Stability is part of our mission to our customers. Recent events have tested our emotions but not our operations, as we have been a remote-first organization for over a year. Our teammates who need personal accommodations are taking them, but on average things are status quo at Enzyme. And we are standing by to assist our customers in this uncertain time.
Aid for SARS-CoV-2/COVID-19 Related Products
We know that teams developing novel coronavirus diagnostic tests and respiratory support devices will have increased pressure to commercialize on aggressive timelines. Enzyme has helped a number of FDA-regulated in vitro diagnostics (IVD) and medical devices get to market.
In the United States, we’ve been slow to respond due to regulatory uncertainty surrounding Lab Developed Tests (LDTs), and accuracy concerns regarding the CDC-developed coronavirus diagnostic test. The US is now aligned on a framework, but we are very much behind-the-curve and scrambling to meet the immense demand for diagnostic tests, their component parts (such as reagents and nasal swabs), and treatment products.
In light of these challenges, we want to support companies developing solutions aimed at the diagnosis or treatment of the novel coronavirus SARS-CoV-2 and its related disease COVID-19.
We are offering:
- Free consulting session regarding Emergency Use Authorization (EUA) filings with FDA
- Free onboarding and 2* months of free access** to Enzyme’s cloud-based electronic Quality Management System (eQMS) platform
- Free access to the Enzyme Community with educational material and regulatory how-tos
* And we’ll increase our free access period if the crisis persists
** For new Enzyme customers
Aid for Teams Going Remote
If you are an existing biopharma or medical device company with a paper-based QMS, you may be wondering how to continue operations when the team is no longer on-site. Enzyme is here to help you. Though it might seem like everyone is focusing on coronavirus-related products to the exclusion of everything else, we realize the importance of ensuring that every other part of our healthcare system continues to function while we as a society align behind solving the threat at hand.
We are offering:
- Free onboarding and 2 months of free access to Enzyme’s cloud-based electronic Quality Management System (eQMS) platform
- Free access to the Enzyme Community with educational material and regulatory how-tos
- Free weekly remote working best practice webinars
Our cloud-based eQMS supports social distancing efforts by ensuring all records are in-sync and digitally accessible in ways paper-based systems cannot.
Note: Such companies that are specifically adjusting to a remote work eQMS environment may be prioritized behind customers who are directly addressing the COVID-19 crisis.
Please contact info@enzyme.com for more information.
