EAS is pleased to welcome Gabriel Muñiz to the EAS Consulting Group team of independent consultants. Gabriel is a distinguished expert in FDA regulatory compliance, quality systems, and risk management, with nearly two decades of experience in tobacco and other FDA regulated product industries. Having served as a Director at the FDA and a senior regulatory leader at Juul Labs, Gabriel brings firsthand knowledge of FDA enforcement strategies, compliance expectations, and regulatory submission requirements. His expertise spans quality management systems (QMS), regulatory risk assessments, data integrity, supplier control, and FDA inspection readiness, making him an invaluable resource for companies navigating complex FDA regulations.
FDA Regulatory & Compliance Expertise. Before transitioning to private industry, Gabriel spent over a decade at the FDA, where he served as an FDA Director and level II Investigator. He was the first-ever Director of the FDA’s Office of Regulatory Affairs (ORA) Tobacco Operations Staff, where he played a pivotal role in shaping FDA compliance and enforcement activities for the tobacco industry. His responsibilities included leading high-profile regulatory investigations, overseeing compliance actions, and collaborating with key enforcement agencies.
Gabriel also held multiple investigative and leadership roles within the FDA, specializing in tobacco product regulation, foods, medical devices, biologics, and bioresearch monitoring (BIMO). He conducted and supervised FDA inspections, developed compliance strategies, and led regulatory enforcement actions, making him a sought-after consultant for companies requiring FDA compliance insights, regulatory defense strategies, and pre-market approval guidance.
Industry Leadership & FDA-Regulated Business Strategy. Following his tenure at the FDA, Gabriel served as Director of Regulatory & Quality Compliance at Juul Labs, where he developed and implemented global quality and regulatory systems to ensure compliance with FDA premarket and postmarket requirements. He successfully led FDA inspection readiness programs, ISO 13485 certification, ISO 17025 accreditation, and regulatory submissions, making him well-versed in the challenges FDA-regulated companies face in balancing compliance and business operations.
His expertise includes:
- Regulatory Compliance & Risk Mitigation– Ensuring companies meet FDA expectations for tobacco and other FDA regulated products
- FDA Inspections & Enforcement– Assisting companies in FDA audit preparation, mock inspections, and 483/warning letter responses
- Quality Management Systems (QMS) & Supplier Controls– Implementing ISO 13485, ISO 17025, and electronic quality systems (eQMS)
- Regulatory Submissions & Litigation Support– Advising on Premarket Tobacco Product Applications (PMTA), Tobacco Product Manufacturing Practices (TPMP), and compliance audits
Strategic Legal Support for FDA-Regulated Clients. Gabriel provides consulting services to law firms, corporations, and regulated entities seeking expert insight into FDA enforcement policies, compliance gaps, and regulatory defense strategies. His deep understanding of FDA operations, regulatory risk, and quality assurance frameworks allows him to assist legal teams in navigating enforcement actions, developing compliance strategies, and mitigating regulatory liability.
With his unique blend of FDA regulatory experience and industry leadership, Gabriel Muñiz is a trusted resource for companies requiring expert guidance in FDA compliance, regulatory risk management, and litigation support.
Posted in EAS in Action, Tobacco.