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Regulatory Buzz

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 CDSIC SEND Implementation Guide 1.0 is now required for NDA submissions of studies started after 18 December 2016. and will be required for IND submissions for studies started after 18 December 2017.

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. It, as well as the SEND 3.1 standards update are currently under CDISC review.

As an active member of CDISC, Xybion participates in the development of these standards. Get the latest on CDISC SEND.


This guidance is intended to describe the Food and Drug Administration’s (FDA’s) current thinking regarding the scope and application of part 11 of Title 21 of the Code of Federal Regulations; Electronic Records; Electronic Signatures (21 CFR Part 11). Get the latest information and guidance from the FDA on 21 CFR Part 11 HERE.

 


The OECD provides a forum in which governments can work together to share experiences, seek solutions to common problems and harmonize regulations. Learn about the OECD GLP and Compliance Monitoring HERE