FDA submission sequencing requires that a sequenced region be determined by complete double-stranded coverage with no less than a 4-fold redundancy in individual reads, which achieves 100% accurate data. All data is collected under Good Laboratory Practices (GLPs) as outlined in the Code of Federal Regulations by the Food and Drug Administration (F.D.A.). SeqWright's unique methods for sequencing through difficult templates can clearly delineate base calls in sequences that are GC-rich or contain secondary structures. Customers are provided with a detailed final report which may be integrated into an application to the FDA or other such regulatory agency. This service is also suitable for use in bioprocessing (biomanufacturing).

All assays are designed custom for a particular project's requirements. SeqWright can work with an assortment of starting materials including cells, isolated DNA or RNA. Please contact us for more information.

SeqWright is the leader in the area of FDA Submission-Quality DNA Sequencing. Our facility is continually audited by private, academic, government and regulatory organizations and agencies. SeqWright is firmly committed to Quality Assurance (QA), and we currently maintain GLP (Good Laboratory Practice) compliance and working on establishing our compliance with GMP (Good Manufacturing Practice).