contractpharmaNovember 12, 2018
Concept Life Sciences, a drug discovery, development and analytical services company, has expanded its regulatory GLP (good laboratory practice) capabilities at its Dundee and Bradford sites. The MHRA has confirmed the extension of Dundee’s in vitro capabilities to cover a range of additional assays, and Bradford can now offer a range of integrated GLP regulatory studies to further support pharmaceuticals, medical devices and healthcare.
The services offered now covers compounds going through pre- and post-clinical regulation studies, eventually up to IND. The company’s regulatory offering now includes assays for enzyme activity, microsomal inhibition, metabolite identification, and cell culture, including hepatocyte induction studies.
The extension is part of a phased plan to expand GXP compliance (including GLP and GMP) at Concept’s facilities across the UK. Concept’s GXP compliance plan will increase the services it offers for the manufacture of API (active pharmaceutical ingredient) material, and enable the group to support the development of compounds from the discovery stage to full IND packages.
John Handley, chief operating officer, Concept Life Sciences, said, "The extension of our GLP accreditation by the MHRA in both Dundee and Bradford enables us to further expand the growing portfolio of services we offer to our clients. The accreditations reflect Concept’s ongoing strategy to implement GXP compliance across multiple sites, and to grow as a company."
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