QualityAssured.ai
We are a team of pharmaceutical quality experts and AI engineers on a mission to transform quality management in regulated industries. Our purpose-built AI tools combine deep industry expertise with cutting-edge technology to help organizations achieve and maintain quality excellence.
Our Story
QualityAssured.ai 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?
We've built a complete suite of AI-powered tools designed exclusively for pharmaceutical and biotech quality teams. Our flagship COG (Compliance Gap) Analyzer provides domain-expert compliance analysis across five key areas: medical devices (ISO 13485), pharmaceutical distribution (DSCSA), cell & gene therapy (21 CFR 1271, BLA, ATMP), aseptic processing (FDA Guidance, Annex 1), and plasma-derived medicinal products (21 CFR 606, 610, 630, 640). Combined with deviation writers, investigation assistants, and audit response generators—every tool is purpose-built for GxP compliance. Our goal is to augment human expertise, not replace it, by handling time-consuming documentation and analysis work so quality professionals can focus on what matters most: ensuring patient safety and product quality.
Our Values
The principles that guide our work
Quality First
We bring decades of pharmaceutical quality experience to every AI system we build, ensuring our tools meet the rigorous standards of regulated industries.
Precision & Accuracy
Our AI models are specifically trained for regulatory compliance, delivering actionable insights rather than generic assessments.
Industry Expertise
Founded by quality professionals who understand the real challenges of GxP compliance, QMS implementation, and regulatory submissions.
Intelligent Automation
We leverage cutting-edge AI to transform time-consuming compliance tasks into efficient, accurate processes.
Meet the Team
Decades of combined experience in pharmaceutical quality and AI
Chris Dayton
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.
Nick Moench
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.
Adam Pinkert
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.
Ready to transform your quality processes?
See how QualityAssured.ai can help your organization achieve quality excellence.