FDA Submission Sanger Sequencing FDA Submission Sanger Sequencing

Next Generation Sequencing Next Generation Sequencing

Plasmid & BAC Production Plasmid & BAC Production

Genotyping Genotyping

MCB Genetic Stability MCB Genetic Stability

GLP LEVEL SERVICES

Good Laboratory Practices (GLP) is a system of management controls that govern research laboratories to ensure the consistency and reliability of each and every result. Codified as federal regulatory standards, GLP provides a governing framework within which laboratory studies are performed, monitored and archived. Compliance with GLP regulations helps to affirm regulatory agencies that a data submission may be rely upon in rendering risk or safety assessments.

GLP regulations are set forth in the Code of Federal Regulations (CFR) at Title 21 CFR §§ 11 and 58 and are administered by the U.S. Food & Drug Administration (FDA).

ACGT fully complies with all GLP standards, including its mandate on equipment design, calibration and maintenance (set forth at 21 CFR §§ 58.61 and 58.63, respectively).