GS Biomark strives to make testing solutions affordable, accessible, and easy to use for all, including underserved communities. Our commitment is to deliver superior value and customer service to our partners.
- Relevant Current Good Clinical Practice (cGCP) requirements:
- As a manufacturing company, RBI complies with GMP (Good Manufacturing Practices).
- Relevant FDA Emergency Use Authorizations (EUA):
- Food and Drug Administration (FDA) registration as a kitting manufacturer. RBI’s FDA registration number is 3008144100. ISO 9001:2015, ISO 13485:2016 and CFR 820.
- RBI is compliant with ISO 13485:2016 and CFR 820.
Experience and Expertise
Our manufacturers have deep experience producing laboratory testing product. We have the capacity, scalability, and supply chain to meet growing demand. Further, we are poised to facilitate shipping to and from multiple locations, provide lab processing of tests, as well as offer tracking and verification for a chain of custody and test result reporting to each student and facility.
Capacity, Scalability and Supply Chain
Our manufacturer maintains ample inventory of the primary components on-hand to meet expected demand, we have flexible systems in place to allow rapid scalability to meet growing demand. We’ve developed robust relationships with supply chain manufacturers and secured ongoing supply agreements to meet increasing demand.
We move fast to meet your requirements with rapid deployment.
Our manufacturer has kitting experience and has been responsive to changing needs during the pandemic, and their logistics teams have experience shipping medical test kits to over 30 countries around the world.