Your Full-Service Global Regulatory, Compliance & Quality Consultancy

From FDA risk management, to business improvements, to enforcement remediation, when Life Science companies need help, they call Compliance Architects^®.

Whether you need to improve quality performance, reduce the number of outstanding NCs or CAPAs, implement new computer-based systems, improve quality documentation, or remediate enforcement risk, Compliance Architects^® can help.  We work with FDA-regulated companies to assess risk, determine strategy, build sophisticated project plans, and develop the systems, processes and procedures that help companies achieve better outcomes from their business, while reducing the risk of FDA enforcement stemming from FDA inspections.

With so many good FDA quality, regulatory, and compliance consultants available, why should you retain Compliance Architects® to assist you with your quality, compliance, and enforcement remediation needs? In short, we have extensive experience, top credentials, and provide greater innovation and business acumen than many compliance advisors currently servicing FDA-regulated industry.

Compliance Architects^® provides comprehensive, hands-on GMP consulting and quality and compliance services to the pharmaceutical, medical device, and biotech industries. Our GMP consultants have experience gained in some of the world’s leading FDA-regulated companies, and bring extensive industry experience with current good manufacturing practices to help you plan, implement, maintain and monitor your  cGMP/GMP compliance.