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Manufacturing facility for testing products

Facility Capacity

Our cGMP manufacture facility is ISO 9001, ISO 13485 certified, US FDA inspected and approved, and designed for large-scale manufacturing of high quality in vitro diagnostic products. Production under cGMP is performed under strict adherence to FDA regulations 21 CFR part 820. SOPs (Standard Operating Procedures) are strictly followed and the batch records are meticulously documented during the manufacturing process by our highly trained staff. The starting raw materials are purchased from high qualified vendors and carefully screened and evaluated by our technical staff prior to use. In our Quality-Control Department, the final product is subjected to a variety of analytical tests using validated methods. Our customers are assured of consistent, reliable and high quality of in vitro diagnostic products. Our commitment is to provide highest quality of products and services with most competitive prices to our customers.

In addition, we specialize OEM/private label manufacturing. Our products can be customized to meet your unique specifications.

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