Quality You Can Count On
Our company was founded to meet the stringent requirements of the research, clinical, and life sciences industries. Our Quality System (QS) is an integral part of everything we do.
All Empirical Bioscience products are developed and manufactured in our facilities under the most rigorous requirements of ISO 13485:2016 from early stage development, technology transfer through manufacturing scale up, validation and full production.
Our Quality System provides validated and fully-documented manufacturing procedures, a certified, traceable supply chain, reproducible products and processes, complete lot traceability, and order tracking.
Empirical assures you of scalability with consistent quality, from development through OEM product manufacturing. Whether you need a standard product, a private label product, a custom manufactured product or a custom kit, we will deliver at the highest quality and the lowest total cost.
Our facilities are FDA registered as manufacturers of Reagents for Molecular Diagnostic Applications. Therefore, virtually all products manufactured in our facility are suitable for use as materials in a wide range of applications, from research, to high-throughput testing and IVD applications.
Our systems approach to products and manufacturing assures that you can have the highest confidence that your quality requirements will always be met at the lowest total cost.
Benefits of ISO Quality System
- Validated Manufacturing Procedures
- Fully Documented Manufacturing
- Certified and Traceable Supply Chain
- Reproducible Products and Processes
- Complete Lot Traceability
- Order Tracking