South Plainfield, NJ – June 14, 2010 -- GENEWIZ, Inc. the largest provider of research-based Sanger DNA sequencing services in the United States, today announced an expansion of its Good Laboratory Practices (GLP) regulatory-compliant DNA sequencing and molecular biology services. GENEWIZ, in partnership with University of Medicine and Dentistry of New Jersey (UMDNJ), is also accredited by the College of American Pathologists (CAP) to provide clinical diagnostic services compliant with Clinical Laboratory Improvement Amendments (CLIA) regulations.
In a recent Quality System evaluation by a certified, independent auditor, GENEWIZ received the highest rating and was selected as a "Supplier approved without restraints.” This comprehensive audit covered 27 major dimensions from incoming sample inspections to data retention. The audit report noted that "GENEWIZ has a Quality System that reflects careful planning and attention to detail. It is evident that GENEWIZ takes quality very seriously and has built quality practices into their production systems. GENEWIZ has the capacity to support large-scale GLP studies supported by a mature quality system.”
The GENEWIZ Quality System ensures quality by design, quality by assurance, and quality by infrastructure. Strict regulatory adherence for GLP studies results in compliant, consistent data for pre-clinical studies and clinical trials. "As the trusted DNA services partner for numerous international pharmaceutical and biotechnology enterprises, we have been asked to expand our GLP practice,” stated Amy Liao, Ph.D., COO and co-founder. "We have the capacity to ensure that our customers can turn to GENEWIZ for their regulatory-submission quality DNA sequencing and molecular biology projects, knowing that they are planned, performed, monitored, recorded, reported, and archived according to FDA guidelines.”
"With our GLP services, customers can expect quality, reliability, and ease of collaboration with our scientific and Quality Assurance teams,” Liao continued. "Dedicated GENEWIZ Study Directors ensure that project goals are fully met, and projects are delivered to our customers’ complete satisfaction.”
GENEWIZ invites prospective clients to email Regulatory@genewiz.com for more information, to schedule an informational meeting or to arrange an on-site audit.
GENEWIZ, Inc. is a contract research organization (CRO) specializing in DNA-based services including DNA sequencing, gene synthesis, molecular biology, genomic and GLP/CLIAregulatory services. The company leads the industry in US research sequencing and outsourcing partnerships with pharmaceutical, biotechnology, academic, and government institutions. Headquartered in South Plainfield, NJ, GENEWIZ is a privately-held, global enterprise with additional laboratory locations in Washington D.C. Metro, Boston, San Diego, and Beijing, China. For more information see www.genewiz.com or call 1-877-436-3949 x3202.