EVVIA LLC

Expert Validation Via Intelligent Automation

Where Regulatory Depth Meets AI

Advisory to guide safe and compliant implementation of

GenAI and AI Agents in regulated GxP areas.

About EVVIA LLC

EVVIA LLC is a boutique advisory firm purpose-built for regulated life sciences organizations at the intersection of GxP compliance, computerized system validation, and the governance of intelligent automation. Founded by Evi Cohen — a 30-year veteran of pharmaceutical research, quality assurance, IP strategy, CDMO leadership, and enterprise technology — EVVIA delivers the kind of senior-level judgment that no staffing augmentation model can replicate.

Evi’s credentials include direct participation as the Generic Pharmaceutical Association’s representative to the FDA 21 CFR Part 11 Coalition during the regulation’s original rulemaking — a distinction held by a vanishingly small number of active practitioners. This foundational regulatory literacy informs every engagement: not as historical context, but as a living framework for interpreting how the FDA’s intent applies to today’s AI-augmented systems, electronic records environments, and agentic automation platforms.

EVVIA operates on a singular conviction: that intelligent automation — when properly validated, governed, and aligned with regulatory intent — accelerates compliance rather than threatening it. Our mission is to ensure that the organizations shaping the future of medicine can deploy advanced technology with full confidence in patient safety and their regulatory posture.

“The FDA wrote Part 11 to intentionally enable innovation under discipline. That principle has never been more relevant than it is today.” — Evi Cohen, Founder

Services

Advisory Services for Regulated Organizations | Nationally and Globally

What is genuinely scarce — and what EVVIA is built to deliver — is the combination of deep regulatory pedigree, enterprise technology fluency, and the senior-level judgment to know exactly where the line is between compliant innovation and regulatory exposure.

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.

Every EVVIA engagement is led by its founder. There is no handoff to a junior team after the initial call, no generic framework applied without context, and no conflict of interest between recommending a technology and validating it. When the FDA asks your organization to justify its compliance posture, you will want an advisor who was in the room when the rules were written.

To schedule an Introduction Call

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evi.cohen@evviallc.com · +1-610-851-9535 · Serving clients nationally and globally

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Credentials & Selected Engagements

A Track Record Built Across Three Decades of Life Sciences Practice

Selected highlights from a career spanning pharmaceutical R&D, GxP quality assurance, IP strategy, CDMO portfolio leadership, and enterprise technology — serving global organizations from top-10 pharma to emerging biotech.

Founding Credentials

Served as the Generic Pharmaceutical Association’s designated representative to the FDA 21 CFR Part 11 Coalition during original rulemaking — one of a small number of industry practitioners with direct formative involvement in this foundational regulation.
30+ years of progressive leadership in pharmaceutical research chemistry, quality assurance, intellectual property strategy, CDMO innovation portfolio management, and enterprise technology strategy.
MBA in Pharmaceutical Management; career spanning regulated manufacturing, global quality systems, and enterprise software go-to-market strategy.

21 CFR Part 11 & GxP Compliance Architecture — Global PaaS Platform

Developed and led the comprehensive 21 CFR Part 11 and Annex 11 compliance strategy for a leading enterprise process automation platform (PaaS) used by regulated life sciences organizations globally. This included defining the platform’s electronic records and electronic signature architecture, authoring GxP compliance guidance for pharmaceutical and biotech customers, and establishing the validation framework applied across dozens of GxP deployments. Resulted in the platform achieving and maintaining broad adoption across top-tier pharmaceutical and CDMO accounts.

GxP Audit Program Leadership — Enterprise Software Platform

Led a sustained GxP audit program for an enterprise technology platform serving regulated life sciences customers. Directed audit readiness strategy, managed on-site audit facilitation, and oversaw CAPA development and closeout across dozens of customer-conducted GxP audits over multiple years. Program consistently resulted in successful audit outcomes, with the substantial majority receiving no observations and the remainder receiving only minor findings — a performance standard that reflects the rigor of the underlying compliance architecture rather than reactive remediation.

Regulatory Submission Infrastructure — Global Top-10 Pharmaceutical Organization

Advisory engagement supporting a top-10 global pharmaceutical organization’s evaluation and roadmap development for AI-augmented regulatory submission infrastructure. Provided strategic guidance on validation requirements, data integrity obligations, and the governance framework necessary to defend automated submission processes under FDA scrutiny.

Pharmacovigilance & Safety Reporting Automation — Large Biotech

Strategic advisory on the GxP validation and regulatory compliance requirements for an intelligent automation platform deployed within a pharmacovigilance and adverse event reporting environment. Addressed electronic records governance, audit trail architecture, and the intersection of agentic automation with 21 CFR Part 11 obligations.

Quality Management System Modernization — Global CDMO

Provided advisory services supporting a global contract development and manufacturing organization’s quality management system modernization initiative. Engagement covered CSV documentation strategy, deviation and CAPA workflow validation, and the regulatory defensibility of an intelligent automation layer within a GMP manufacturing environment.

LinkedIn: https://www.linkedin.com/in/evicohen/