Clive Seymour

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haemoglobin controls biotechnology research oem ivd controls calibrators hba1c controls quality control hbfasc controls hba2 controls -thalassemia testing diabetes testing hemoglobin variant testing serum controls plasma controls lyophilized controls bulk supply custom products process scale chromatography iso 13485 cgmp compliance fda listed ce mark quality management system continuous improvement automated filling systems container closure packaging design regulatory support stability testing reconstituted controls substantial shelf life multi-level controls analytical methods ion exchange hplc immunoassay boronate affinity electrophoresis capillary electrophoresis liquid control stability studies customer specifications clinical diagnostics control kits kitting solutions quality objectives non-sterile dsr products flexible product supply technical resources safety data sheets compliance audits