Regulatory and Quality Assurance

Cellular Technology Limited has integrated regulatory and quality assurance oversight throughout its operation to ensure that our Products/Services meet the unique challenges and requirements of our customers.

Contract Laboratory Services

Our contract laboratory is CLIA/CLEP-certified and follows FDA/ICH regulations/guidelines.

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ePBMC®, ImmunoSpot® Kits, Antigens Controls, batch/lot testing, quality control and characterization analysis

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ImmunoSpot® Analyzers

The ImmunoSpot® Analyzer Quality Management System is ISO-9001:2015 certified, and built to support 21 CFR Part 11 conformity requirements

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