XCellR8’s commitment to quality

At XCellR8, we strive to achieve the highest quality in all that we do.

Our Good Laboratory Practice (GLP) accreditation by the UK’s MHRA (Medicines and Healthcare Products Regulatory Agency) qualifies us to provide our clients with in vitro safety test data that can be used at a regulatory level, for compliance with a wide range of European and global regulations.

We apply a single quality standard to all of our work, ensuring that even tests without formal regulatory approval are conducted to the same high standard in our GLP accredited laboratory.

Our commitment to quality is firmly embedded in our company culture and values, providing you with reassurance that every member of the XCellR8 team is passionate about playing their part in helping you to achieve regulatory compliance for your products.

A NOTE ON REGULATORY COMPLIANCE FOR IN VITRO TESTS

Prior to gaining regulatory approval, an in vitro method must undergo a rigorous process of international validation, using an extensive panel of reference chemicals to confirm the predictive capacity of the test. The data is scrutinised by a global panel of experts and only after a comprehensive review is the test approved for regulatory use (usually as an OECD Test Guideline). The entire process, from research bench to full approval, can sometimes take a decade or more. This validation process was never required for traditional animal tests, so the strict criteria required today reflect the higher standards of rigorous science required to achieve regulatory approval for in vitro methods, building confidence in their robust performance to ensure human safety.

Read more about some of the key regulations we are compliant with on our Regulatory Compliance page.

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