Selcia Limited, the international life sciences CRO, has announced a successful inspection of its GMP radiochemistry facility by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
This has resulted in the granting of a new Good Manufacturing Practice (GMP) certificate for the preparation and 14C labelling of Active Pharmaceutical Ingredients (APIs).
Commenting, Selcia’s CEO, Dr Hans Fliri said: “The preparation of 14C-APIs under GMP continues to be a strong offering from Selcia to our customers who require material suitable for use in clinical trials. Selcia has again demonstrated the impressive quality of its radiolabelling services”.
Director of Radiochemistry Dr Gill Little said: “The certification of our GMP 14C-API facility is confirmation of the world class standards attained by Selcia’s hard-working dedicated radiochemistry and QC teams who successfully deliver many GMP and non-GMP 14C-radiosynthesis projects every year”.
Selcia is a privately held company providing both 14C radiolabelling and integrated drug discovery services, operating from a modern facility in Ongar, Essex, UK.
Selcia’s radiolabelling division produces C-14 radiolabelled compounds 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 studies; mass balance, microdosing, research and regulatory studies; and environmental fate studies.
Selcia’s analytical laboratory is a member of the UK GLP Compliance Monitoring Programme.
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For further details about Selcia’s Radiolabelling service please contact
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