_____________________________________________________________________________________________ Abingdon
Health
Abingdon Health also owns and operates an e-commerce platform where it sells its Simply Test range of self-tests
on to detail some of the key benefits to the business : “ Our new additions to the group , Compliance Solutions ( Life Sciences ) and IVDeology , provide complementary regulatory services to customers looking to bring products to market in the medical device industry , with services to help customers navigate the various regulatory frameworks of the different territories in which they operate . This completes the ‘ one-stop-shop ’ for development through to scale up and manufacturing . The pending addition of an analytical services laboratory that provides performance evaluation of products will further complement the suite of services being offered . Along with the regulatory services , this will allow us to make a significant contribution to a product ’ s regulatory technical file . This will include product stability testing , specificity , sensitivity , assessment of detection limits , interference , crossreactivity testing and method comparisons . The technical file is a key requirement for regulatory approval by FDA , EU IVDR , UKCA and other regulatory authorities . The analytical laboratory will be able to perform this work for lateral flow assays as well as other in vitro diagnostic tests including enzymelinked immunosorbent assay ( ELISA ) and molecular diagnostic tests .”
On top of significant recent acquisitions , the company has also opened a new facility in the US , in Madison , Wisconsin , leasing space in the MGE Innovation Center at University Research Park . The site includes a new lab , production facilities as well as
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