About

Monarch Global Health is a Florida-based diagnostic healthcare company established with a goal of excellence in quality, and advancing healthcare through innovation and testing technology, thus leading to excellence in patient outcomes and efficient results.

The goal of Monarch Global Health is to provide the best in COVID 19 Antibody and Antigen testing with production, development, and manufacturing in the United States. Securing timelines and insuring availability through streamlined manufacturing processes and exceeding quality goals are at the foundation of what we do and who we are as an organization.

Production is performed in two 30,000 Sq. Ft. manufacturing facilities located in Ocala, Florida following ISO 13485:2016, ISO 9001:2015, and FDA 21 CFR Part 820. We have the capacity to increase production to well over 1,000,000 units per week.

Monarch has invested in a unique manufacturing technique utilizing semi-automatic machines that will be on-line in 3Q, 2020.  This production method consists of semi-automated machines that will develop 25-30 kits a minute or approximately 44,000 per day.  Each production room will hold three semi-automatic machines allowing Monarch to increase production based on demand.

Our number one priority at Monarch is quality control processes. It is our protocol to test each lot run by pulling the 1st test kit, last test kit, and a test kit every hour for quality assurance testing.  Quality Control test kits are taken into our quality control room where QC measures are used to confirm consistency and accuracy in the creation of Monarch Global Health test kits.

Performing in a highly regulated industry with strict quality requirements, Monarch Global Health implemented manufacturing processes that demand perfection and consistency.

We are diligent in our Quality Control procedures and volume commitments, but most importantly we are committed to developing and producing the best USA made product to the communities we serve and worldwide.

If you would like to learn more about Monarch Global Health, please send us an inquiry through the contact us page. We look forward to engaging partners who share our commitment to advancing healthcare through innovation and testing technology.

MONARCH GLOBAL HEALTH MISSION

Advancing healthcare through innovation and testing technology.

Core Values

Monarch Global Health’s core values are built around Commitment, Consistency, and Community
Monarch Global Health - Young people on mountain hike at sunset

COMMITMENT

Monarch strives to deliver products and services of unsurpassed quality and commitment.

in delivering healthcare products to the communities we serve

CONSISTENCY

Monarch Global Health strives for the efficient delivery of products we manufacture.

null

COMMUNITY

Monarch Global Health is dedicated to supporting communities in returning to the lifestyles they love.

Standards

Monarch Global Health works with the US Food & Drug Administration and we comply with the Code of Federal Regulations, Title 21, Part 820 (FDA 21 CFR 820). This includes the US Quality System Regulation (QSR) and Good Manufacturing Practices (cGMP and GMP) for medical devices.
Monarch’s ISO 9001:2015 and 13485:2016 certifications and Class 8 Clean Room status shows that facilities adhere to some of the most strict quality assurance processes.