About Us
Lepzi Biotechnology Ltd.,based in Richmond, Canada.Our team brings together professionals with extensive experience in design and development of point-of-care medical devices, from early-stage prototyping and reagent development to implementation of specialized manufacturing and quality control processes.
Lepzi Diagnostika Ltd., based in Sofia, Bulgaria.We are innovative company working in the field of high-performance technologies for medical diagnostics and medical care. Our team consists of professionals with extensive experience in the design and development of medical devices, prototypes and reagents to the application of specialized processes for production and quality control. Lepzi Diagnostika provides an advanced platform for immunoassay that allows a rapid flow of diagnostic information for improvement of the medical care.
Our Quality Management System is ISO 13485:2016 registered and it creates a reliable framework for development and manufacture of critical assay components for the LEPZI platform.
Lepzi has got CE marking. As the manufacturer,Lepzi is now responsible for the design, manufacture and control of the registered medical device (s) and its assessment in accordance with the essential requirements of the Medical Devices Act and its implementing acts, which introduce Directive 98/79 / EC and other relevant regulations.
Products
Partners
Our philosophy is that the challenges faced by the healthcare providers worldwide can only be solved by bringing together partners with a diverse expertise in biomarker discovery, clinical research, product development, manufacturing and commercialization.
LEPZI assay platform licencing to facilitate the introduction of novel biomarkers for medical diagnostics.
Distribution partnerships to facilitate the introduction of reliable and cost- effective diagnostic solutions in different parts of the world.
Cooperation in building global manufacturing capabilities to address the unique demands of each market.
Events