We are a team of pharmaceutical quality experts and AI engineers on a mission to transform compliance analysis in regulated industries. COG combines deep industry expertise with advanced AI to help organizations achieve and maintain quality excellence.
Quality Assured Artificial Intelligence LLC was founded by life sciences professionals who experienced firsthand the challenges of maintaining compliance in complex regulatory environments. After years of manually reviewing documents, building quality systems, and preparing for audits, we asked: what if AI could help quality teams work smarter, not harder?
COG—the Conflict Overlap Gap Analyzer—was born from this vision. Unlike generic AI tools, COG is purpose-built for GxP compliance, trained on the specific language and requirements of ISO 13485, DSCSA, and other regulatory frameworks. Our goal is to augment human expertise, not replace it, by handling the time-consuming analysis work so quality professionals can focus on what matters most: ensuring patient safety and product quality.
The principles that guide our work
We bring decades of pharmaceutical quality experience to every AI system we build, ensuring our tools meet the rigorous standards of regulated industries.
Our AI models are specifically trained for regulatory compliance, delivering actionable insights rather than generic assessments.
Founded by quality professionals who understand the real challenges of GxP compliance, QMS implementation, and regulatory submissions.
We leverage cutting-edge AI to transform time-consuming compliance tasks into efficient, accurate processes.
Decades of combined experience in pharmaceutical quality and AI

CEO
With a decade of experience in protein, cell, and gene therapy manufacturing, Chris has served as a lead investigator, QMS author, and technical operations manager overseeing QDS authorship and validation approvals.

CTO
Nick Moench is an upstream SME with over 10 years of bioprocessing experience and a visionary AI architect. As CTO, he leads the design of intelligent systems that fuse pharmaceutical expertise with cutting-edge technology to transform quality in regulated environments.

Sr. Advisor: Quality and Regulatory
Biotech quality consultant and executive with 30+ years of experience in GxP compliance, FDA remediation, quality systems implementation, and regulatory strategy. Proven track record leading inspection readiness, supplier quality management, biotech/CGT operations, and aseptic manufacturing from Phase I through commercial launch.
See how COG can help your organization achieve quality excellence.