Selcia Limited, a global leader in 14C radiolabelling and integrated drug discovery service provider, has received GLP re-certification for its analytical laboratory following a successful Good Laboratory Practice (GLP) inspection by the UK Medicines and Healthcare products Regulatory Agency (MHRA).
Selcia has been a full member of the GLP Compliance Monitoring Programme in the UK since 2006 and specialises in providing GLP certified radiolabelled compounds for use in regulatory studies and GLP analysis including mass spectrometry, FT IR and GLP NMR (including capillary NMR) on standards, metabolites and impurities to support regulatory submission. The re-certification follows on from Selcia’s 20th anniversary of radiosynthesis at its Ongar HQ site earlier this year.
Commenting on the news Dr Gill Little, Director of Radiochemistry said; “Together with our MHRA GMP certificate for 14C radiolabelled APIs, the GLP re-certification demonstrates our commitment to support our clients by producing compounds and data that are suitable for regulatory submissions."
Selcia Limited (www.selcia.com)headquartered in Ongar, Essex, UK, operates two divisions: Selcia Discovery and Selcia Radiolabelling.
Selcia Radiolabelling is a leading provider of 14C custom radiolabelling and produces 14C radiolabelled compounds and 14C GMP radiolabelled APIs for a global customer base encompassing both the life sciences and chemical industries. Applications of the radiolabelled products prepared by Selcia include: preclinical and clinical drug metabolism, mass balance, and microtracer studies; research and regulatory studies of cosmetic products; and environmental fate studies of pharmaceutical, agricultural and industrial chemicals. Selcia’s analytical laboratory is a member of the UK GLP Compliance Monitoring Programme and specialises in GLP NMR.
Selcia Discovery provides integrated small molecule drug discovery to pharmaceutical and biotech clients. Besides general medicinal chemistry and biology capabilities applicable across all target classes, Selcia Discovery has a particular strength in three unique and highly synergistic technologies: (1) medicinal chemistry on complex natural products, (2) capillary electrophoresis -based fragment and natural product screening, (3) Protein-Protein interaction targets in particular peptidyl-prolyl isomerases (including cyclophilins, FKBPs, Pin1, together called PPIases).
Key Contact: Dave Roberts, Business Development Director - Radiolabelling
Phone No: +44 (0) 1277 367000