About Ethagis
A compliance, regulatory, and quality consultancy dedicated to helping life sciences organizations achieve operational excellence and regulatory success.
Advancing Patient Safety Through Compliance Excellence
Ethagis collaborates with clients to help develop and market products that deliver exceptional value to patients. We leverage decades of industry experience to provide consulting services that meet FDA and other regulatory body requirements.
Our mission is simple: to help organizations navigate the complex regulatory landscape while maintaining the highest standards of quality and compliance. We believe that regulatory compliance isn't just about meeting requirements—it's about protecting patients and ensuring that safe, effective products reach those who need them.
The Ethagis Name
Combining Ethical + Aegis — representing integrity and protection.
Principles That Guide Us
Our core values define who we are and how we work with every client.
Integrity
We uphold the highest ethical standards in all our engagements, ensuring transparent and honest partnerships.
Trust
We build lasting relationships based on reliability, consistency, and a commitment to your success.
Honesty
We provide candid assessments and recommendations, always prioritizing your best interests.
Compliance
We are dedicated to helping you achieve and maintain the highest standards of regulatory compliance.
Dave Lonza
Managing Partner
Expertise You Can Trust
FDA Experience
Our team includes former FDA professionals who understand regulatory expectations from the inside.
Global Reach
Extensive international experience supporting clients with global regulatory requirements.
Industry Veterans
Senior experts with decades of combined experience in FDA-regulated industries.
Tailored Solutions
We formulate fit-to-need solutions designed for each client's unique challenges.
Industries We Serve
We support organizations across the life sciences spectrum.
Medical Devices
Combination Products
Pharmaceutical Therapies
Biotech Products
Cell & Gene Therapy
Meet Our Leadership Team
Get to know the experienced professionals who lead Ethagis and bring decades of industry expertise to every engagement.
View Leadership TeamReady to Advance Your Compliance Goals?
Partner with Ethagis for expert guidance in regulatory compliance, quality management, and strategic consulting. Let's discuss how we can help your organization succeed.