Xybion’s solutions are purpose-built to help our clients meet the ever-changing demands of highly regulated industries. As such, we actively track and participate in a variety of regulatory environments. We focus on FDA 21 CFR Part 11, all aspects of GxP including GLP (Good Laboratory Practices) and GMP (Good Manufacturing Practices) and CDISC SEND Submission requirements. Below are some links to industry sites/resource centers to help you stay ahead of the curve.
The CDISC SEND Implementation Guide: Developmental and Reproductive Toxicology (SENDIG-DART) v1.0 draft supports study data typically found in embryo-fetal developmental (EFD) toxicity studies and is based on the SENDIG for single-dose general toxicology, repeat-dose general toxicology, and carcinogenicity studies. Get the latest on CDISC SEND.