EVVIA LLC
Intelligent Automation Meets Regulatory Excellence
About EVVIA LLC
EVVIA LLC is a boutique advisory firm at the intersection of life sciences regulatory compliance and intelligent automation. Founded by Evjatar (Evi) Cohen, a highly credentialed expert with over 30 years of experience across pharmaceutical research, quality assurance, IP strategy, CDMO leadership, and enterprise technology, EVVIA delivers deep, practical expertise to regulated organizations worldwide. Evi’s unique background includes direct engagement with the FDA during the development of 21 CFR Part 11 as a representative of the Generic Pharmaceutical Association, providing rare insight into the foundations of modern electronic records and compliance standards.
EVVIA operates on the principle that intelligent automation—when properly validated and governed—accelerates regulatory compliance rather than hindering it. We support clients globally with strategic guidance that bridges regulatory rigor and advanced automation, helping organizations navigate the complex landscape of AI governance, data integrity, and computerized system validation. Our mission is to empower life sciences companies to leverage cutting-edge technology while maintaining the highest standards of regulatory compliance and quality assurance.
Our Services
AI & Computer System Validation
Comprehensive AI-centric Computer System Validation (CSV) and GxP Quality Systems for Computerized Systems. We ensure your automated systems meet regulatory requirements while maintaining data integrity and compliance with industry standards.
Regulatory Compliance & Data Integrity Advisory
Expert guidance on 21 CFR Part 11 and Annex 11 compliance. Our deep regulatory knowledge helps organizations implement electronic records systems that satisfy FDA requirements and maintain the highest standards of data integrity and security.
AI Governance & Regulatory Strategy
Strategic advisory on AI Governance, Agentic Automation Compliance, and FDA engagement. We help regulated organizations develop robust governance frameworks for intelligent automation while navigating complex regulatory landscapes and preparing for FDA interactions.