FDA Quality and Regulatory Consultants (FDAQRC) — a compliance solutions provider for pharmaceutical, biotech and medical device companies — has officially acquired Compliance Architects LLC as of 17 July, 2026.

Compliance Architects provides quality, regulatory and compliance-related services to companies regulated by the United States Food and Drug Administration (FDA). This strategic acquisition unites two industry-leading, privately held consulting firms to create a stronger and more comprehensive service portfolio for FDA-regulated life sciences companies.

Two Approaches, One Comprehensive Solution

FDAQRC and Compliance Architects are both trusted leaders in FDA compliance. Each brings distinct strengths and capabilities that support life sciences companies in achieving quality assurance and regulatory compliance. Our firms approach the same mission from different ends of the product life cycle.

FDAQRC’s expertise is rooted in clinical and laboratory compliance, emphasizing study conduct, data integrity, and clinical trial conformity, including good clinical practice, good laboratory practice and Bioresearch Monitoring. A global network with former FDA investigators and industry veterans provides this expertise. Compliance Architects specializes in commercialization-stage quality and regulatory support, with deep expertise in good manufacturing practice compliance, operational quality systems, complex enforcement response and inspection preparedness.

Together, these expansive capabilities provide FDA-regulated companies with world-class support options for quality, regulatory, and compliance challenges. When you need both services, you get professional guidance without a handoff between vendors or a gap in institutional knowledge.

Combined Capabilities

FDAQRC’s customized, value-added solutions help businesses improve efficiencies while minimizing regulatory risk. Our full-time team and global consultant network are made up of quality and compliance professionals who have technical and scientific expertise across human trials, laboratories and manufacturing environments.

Compliance Architects’ capabilities complement FDAQRC’s service offerings:

  • Complex FDA enforcement response, planning and remediation
  • Supply chain supplier, contract development and manufacturing organization, and related audits and assessments
  • Inspection readiness training and services
  • Outsourced compliance services
  • Regulated software and technology solutions
  • Quality system redevelopment or implementation

With extensive experience and professional expertise, Compliance Architects enables organizations of any size to significantly improve their FDA compliance outcomes.

FDAQRC and Compliance Architects Leadership Unite to Advance FDA Compliance Excellence

Christopher Rush, president and founder of FDAQRC, and Jack Garvey, president and founder of Compliance Architects, bring complementary expertise and a unified commitment to advancing FDA compliance across the life sciences industry. The merger of these two firms reflects that shared purpose.

Mr. Rush has previous experience working for the U.S. FDA, inspecting over 50 facilities in the pharmaceutical and bioresearch monitoring industries. After an award-winning career, he left the FDA in 2007. His next role was with a global in vitro diagnostic manufacturer, where he oversaw manufacturing and supply chain, FDA submissions, and follow-up correspondence. In 2009, Rush founded FDAQRC. His experience soon evolved FDAQRC from a small business to a global leader.

Mr. Garvey is an FDA quality, regulatory and compliance expert with 40 years of diverse industry and consulting experience. He has supported quality, regulatory, and compliance operations for some of the world’s largest and most respected life science companies. His background as a chemical engineer and attorney gives him a unique perspective on the challenges these companies face at the intersection of science, law and business. He uses traditional and proprietary approaches to reduce enforcement risk and improve operational outcomes.

How Our Shared Solutions Make a Strategic Impact in the Future of Compliance

Proprietary solutions, tools and teams originating from Compliance Architects will be backed by FDAQRC's global consultant network spanning over 70 countries to improve FDA inspection outcomes for our clients and help align business decisions with regulatory expectations. These solutions include:

  • Writing for Compliance®: The Writing for Compliance workshop training program elevates writing skills for quality and operations teams. The goal is to improve the outcomes of FDA and other regulatory inspections. This program is the first of its kind and the only FDA-regulated training program specifically designed to improve FDA inspection outcomes through better writing.
  • Quality Pulse®: The Quality Pulse quality culture diagnostic uses a behavior-based assessment approach to determine an organization’s quality culture using advanced data analytics. These measurements of quality culture position companies to make meaningful improvements and drive lasting results.
  • CRPN Quality Roadmap®: This highly structured service helps life science manufacturers with risk-based planning backed by data-informed decisions. The proprietary risk and complexity algorithms assess and prioritize risks and optimize resource allocation. With the CRPN Quality Roadmap, companies can make confident, strategic quality planning decisions that align with their business goals.

The team you work with, the quality of the work, the responsiveness, and the proprietary methodologies to improve inspection outcomes will stay the same. The key difference is the broader bench of expertise available to support you, from early clinical development through commercial manufacturing and post-market compliance.

 

 

Contact Us for More Information

FDAQRC and Compliance Architects are looking forward to how uniting as one company will streamline compliance and risk mitigation for our clients. To learn more about our partnership, contact us today.