Concept Life Sciences extends GLP accreditation to support regulatory studiesNovember 9, 18
- MHRA confirms GLP extension at Dundee and Bradford sites
- Accreditation ensures quality and integrity of non-clinical laboratory studies to support pharmaceutical and biotech industries
Manchester and Dundee, UK, 07 November 2018: Concept Life Sciences (“Concept”), the integrated drug discovery and development and analytical services company, today announced the expansion of its regulatory GLP (good laboratory practice) capabilities at the Group’s 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 breadth of services offered to customers at all stages of discovery and development now also covers compounds going through pre- and post-clinical regulation studies, eventually up to IND. In addition to its original non-regulatory services, the Company’s regulatory offering now includes a wide range of assays for enzyme activity, microsomal inhibition, metabolite identification, and cell culture, including hepatocyte induction studies.
The extension forms 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 further support the development of compounds from the discovery stage to full IND packages, providing increased assurance of data integrity and compliance with international standards to ensure acceptance of data by global regulatory bodies.
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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