FDA Support

We provide DNA sequence analysis to support product applications to the FDA. Our procedures and standards are compliant with US FDA regulations covering GLP (21 CFR 58). The service includes a comprehensive DNA sequence analysis as described in individual project protocols with SOPs that cover all procedures starting with sample receipt to data delivery and archiving. Each project is guided by a designated Study Director who oversees all the steps of the work from sample receipt to final data delivery. Each project is evaluated by our independent Quality Assurance Unit personnel to ensure the quality and integrity of the study.

FDA Quality DNA Sequencing Service features Phred 30 - Phred 40 quality base data with 4-6 fold coverage at each base. The sequencing results will be presented in a comprehensive report that can be incorporated into an application for FDA approval. The sequence data and project-related samples and records will be archived after the completion of the analysis as detailed in Title 21 CFR.