Quality systems for clinical and regulatory compliance |  | ISO 13485:2003 certification confirms that IDT meets the rigorous standards required for the supply of custom manufacturing/processing services, customer support and sales distribution of molecular biology products for molecular in vitro diagnostic devices and licensed nucleic acid tests. This dedicated manufacturing suite, with its additional compliance with FDA 21 CFR Part 820 QSR/cGMP and 21 CFR Part 864.4020 Analyte Specific Reagents, positions IDT to better serve both current and future clinical/medical device customers. It will also be important for commercial customers with applications that need a higher level of process control and compliance.
| This arrangement allows IDT to further improve service by offering dedicated processing, purication, analysis, formulation, functional testing and final fill services in purpose-built controlled environment suites with assigned senior production staff. IDT’s enormous investment in quality manufacturing – pioneering efforts in 100% mass spec QC, purity guarantees for purified oligos, industry-leading Raw Material QC, processing and reagent production infrastructure – has helped solidify the company as a respected world leader in nucleic acid synthesis. Now IDT is able to assure customers that their specific diagnostic oligo needs can and will be met through all regulatory channels.
| For more information, please contact a Clinical and Commercial Manufacturing account representative at ccminfo@idtdna.com
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