About Compliance Architects

Compliance Architects delivers compliance and quality consulting, outsourcing, staff augmentation, and technology-related services to companies directly regulated by the United States Food and Drug Administration (FDA).

With service capabilities ranging from quality systems implementations to audits, outsourced compliance services, inspection readiness and complex enforcement remediation, Compliance Architects has the experience, expertise and delivery capability that will result in significantly improved FDA compliance outcomes for any size organization.

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Who We Serve

Consulting Services For Global Life Sciences

Compliance Architects serves the pharmaceutical, medical device, dietary supplement, biologics, cosmetic, and food industries – in short, any industry regulated by the US FDA. Our clients range from small, family-owned companies to the world’s largest and most diversified healthcare-manufacturers. We operate globally, and have the flexibility and scale to support companies with a variety of different business models, from consolidated, vertically-integrated organizations to de-centralized, virtual organizations. No matter where you are located, if your organization and/or products are regulated by the US FDA, we can help you manage and reduce your risk from adverse compliance enforcement outcomes, which in turn helps your business and your bottom line.

Global Reach

Providing solutions to businesses worldwide.

Industry Expertise

Supporting a variety of FDA-regulated industries.

Expansive Capability

Operate at strategic or tactical level.

Advocacy Through Science

Creating solutions to mitigate unfortunate risk.

Leadership Spotlight

Driving innovation in compliance and quality.

Working at Compliance Architects is deeply rewarding. We help life science businesses succeed financially while ensuring healthcare products are safe and effective. By supporting innovation and compliance, we help clients thrive—because when they do, patients gain access to safe, groundbreaking treatments. A true professional win-win.”

Working at Compliance Architects is deeply rewarding. We help life science businesses succeed financially while ensuring healthcare products are safe and effective. By supporting innovation and compliance, we help clients thrive—because when they do, patients gain access to safe, groundbreaking treatments. A true professional win-win.”

Jack Garvey

Managing Partner

“A big part of my job as COO is to make sure Compliance Architects is best-in-class in the design, development, and delivery of solutions for companies in FDA-regulated industry. I work closely with our senior leadership team and our clients on projects and capabilities which yield outstanding results that meet or exceed customer expectations.”

“A big part of my job as COO is to make sure Compliance Architects is best-in-class in the design, development, and delivery of solutions for companies in FDA-regulated industry. I work closely with our senior leadership team and our clients on projects and capabilities which yield outstanding results that meet or exceed customer expectations.”

Jerry Appert

Chief Operating Officer

"Quality drives success in the pharma/biopharma and medical device industry. It is not simply a cost driven by “compliance with regulations”. Quality, when approached strategically, can drive innovative breakthroughs in product research and development, production, distribution, product lifecycle management, and ultimately patient experience."

"Quality drives success in the pharma/biopharma and medical device industry. It is not simply a cost driven by “compliance with regulations”. Quality, when approached strategically, can drive innovative breakthroughs in product research and development, production, distribution, product lifecycle management, and ultimately patient experience."

Teresa Gorecki

Practice Director

“In my 40+ years in the life-science industry, my focus was always on GxP’s and Quality; whether in manufacturing, training, or staff support functions. Why? Because we weren’t making brooms!”

“In my 40+ years in the life-science industry, my focus was always on GxP’s and Quality; whether in manufacturing, training, or staff support functions. Why? Because we weren’t making brooms!”

Randall Lumia

Vice President of Human Resources

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