Quality
LGC Biosearch Technologies fully understands that quality is of utmost importance to customers as poor quality reagents and oligos can ruin even the best-designed assays.
Quality Policy:
LGC Biosearch Technologies is a global leader in the areas of oligonucleotide and specialty chemical manufacturing. We are committed to maintaining this leadership position by providing customers with innovative products and exceptional, on-time service. We achieve these goals by remaining focused on continuous controlled improvement and meeting or exceeding customer and regulatory requirements.
Quality at LGC Biosearch Technologies:
The Quality Management System in place at LGC Biosearch Technologies has been developed to be fully compliant with ISO 9001:2008 Quality Management Systems – Requirements; or ISO 13485:2003 Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes and 21 CFR Part 820 – Quality System Regulation, as applicable to our GMP and Commercial Services production group.
LGC Biosearch Technologies carries the following certifications, registrations and/or licenses:
- ISO 9001:2015 – British Standards Institute (certificate registration number: 590012, View Certificate)
- ISO 13485:2016 – British Standards Institute (certificate registration number 592939, View Certificate)
- US Food and Drug Administration Establishment Registration as a Medical Device Manufacturer (registration number 3003009052)
- California Department of Public Health Food and Drug Branch Device Manufacturer (license number 72147, View Certificate)