AutomatingIntegrity.DefiningCompliance.
QA²I delivers AI tools for the world's most regulated manufacturers, producing audit-ready compliance documentation in a fraction of the time and cost of manual work.
The real cost of manual quality documentation
EU GMP-regulated pharmaceutical manufacturers must produce a continuous stream of quality documents: supplier audits, product quality reviews, regulatory submissions, and more. Each requires days of manual preparation by senior QA professionals.
Existing solutions store and track documents but do not generate them. The work remains entirely manual, consuming expensive expert capacity that should be focused on judgment-intensive decisions.
Why QA²I
QA²I combines Quality Assurance and Artificial Intelligence, with the "²" symbolizing QA amplified by AI.
The founding conviction
We started QA²I with a single belief: that the most important documents in pharmaceutical manufacturing, the ones that prove product safety and process control to regulators, should not be the ones most prone to human error and delay.
Our ambition isn't to remove humans from compliance. It is to give the experts the most capable assistants. The AI handles what's repetitive: reading, cross-referencing, drafting. The expert handles what matters: verifying, judging, deciding. AI that reasons across data, prepares documents with domain fluency, and defers to human judgment at every gate. Less time assembling, more time deciding.
The team behind QA²I
Ivan Lugovoi
Co-Founder & CEO
Brings over a decade of pharma leadership as CEO of a Swissmedic-approved distributor and Managing Director of an anticancer API producer approved by the US FDA, EMA, and PMDA.
Max Guba
Co-Founder & COO
Combines a background in AI, business, and regulated industries, supported by research on AI implementation in pharma compliance. Focuses on business development and daily operations at QA²I.
Alexandre Lugovoi
Co-Founder & AI Engineer
Grounded in computer science and machine learning, with research experience at ETH Zurich in neural decoding and data engineering. Architects the systems that make AI outputs auditable and deployable in regulated environments.
Domain depth, staged execution
QA²I uses AI agents to automate preparation of compliant, traceable pharmaceutical quality documents. Specialized agents handle document ingestion, cross-document consistency checks, regulatory criteria matching, and structured output generation within a validated pipeline.
Every output traces back to source documents, satisfying EU GMP Annex 11 and ALCOA+ requirements. Human experts review and approve all outputs. The result is audit-ready documentation produced in a fraction of the time and cost of manual preparation.
Affiliations & collaborations
Transform your compliance documentation.
See how QA²I's AI pipeline can turn weeks of manual document work into days, with full audit transparency.
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