Our Company

Pioneering Diagnostics Since 1998

For over 25 years, BioSynth Labs has been at the forefront of in-vitro diagnostic innovation, developing and manufacturing diagnostic solutions that laboratories around the world depend on every day.

Our Mission

To improve global health outcomes by delivering high-quality, accessible diagnostic solutions that empower healthcare professionals to make accurate and timely clinical decisions. We are committed to innovation, quality, and partnership with laboratories worldwide.

Our Vision

To be the world's most trusted partner in diagnostics — recognized for exceptional quality, continuous innovation, and unwavering commitment to advancing laboratory medicine across every continent.

BioSynth Labs by the Numbers

25+
Years of Innovation

Developing world-class IVD solutions since 1998

500+
Products

ELISA kits, reagents, instruments, and custom solutions

50+
Countries Served

Distribution network spanning every continent

10K+
Lab Partners

Trusted by clinical and research labs worldwide

Our Journey

Key Milestones

1998

Company Founded

BioSynth Labs established in Sainte-Foy, Canada, with a focus on immunoassay development.

2003

ISO 13485 Certified

Achieved ISO 13485 quality management system certification for medical device manufacturing.

2007

CE Marking Obtained

Received CE marking for our ELISA kit portfolio, enabling distribution across the European Union.

2012

Global Expansion

Expanded distribution network to 30+ countries with regional offices in Europe and Asia.

2016

500th Product Launched

Reached a milestone of 500+ diagnostic products across ELISA, biochemistry, and instrumentation.

2020

OEM Services Launch

Opened dedicated OEM manufacturing facility for private labeling and custom formulation.

2024

Next-Gen Platform

Launched next-generation diagnostic platform with AI-assisted quality control and global compliance.

Quality & Certifications

Our commitment to quality is validated by the world's most rigorous regulatory standards.

ISO 13485:2016

Quality Management System for Medical Devices — design, development, production, and servicing.

CE IVD Marked

European CE marking for in-vitro diagnostic medical devices under the IVDD/IVDR framework.

FDA Registered

Registered with the U.S. Food & Drug Administration for diagnostic product distribution in the United States.

Partner With BioSynth Labs

Whether you need diagnostic products, OEM manufacturing, or custom formulations — let's build the future of diagnostics together.