“Quality is one of our highest priorities.”
Margaret Hamburg, US FDA Commissioner, 22 Feb 2013
Compliance Architects® can help you improve your quality and compliance outcomes with innovative approaches focused on remediating the structural causes of quality and compliance risk. Contact us now and reduce your FDA enforcement risk today!
Responding to FDA enforcement actions (FDA 483 observations & warning letters) requires the ability to integrate FDA quality systems and compliance expertise under an umbrella of rigorous project and program management, to ensure committments are strictly monitored and deliverables accomplished. Compliance Architects® can provide the leadership, expertise and resources to resolve the most complicated and risky enforcement actions.
A “perfect storm” of events has created significant compliance risk for FDA-regulated companies. Every company MUST have a robust supplier quality and audit program in place or, their entire supply chain could be at risk! Compliance Architects® has developed a breakthrough supplier quality audit and quality management program. Contact us now and reduce your supplier quality enforcement risk TODAY!
It has never been more important to be “ever-ready” for an FDA inspection. Without expert guidance on readiness approaches, a company is at the mercy of FDA Investigators and may experience significant remediation costs, distraction from business objectives, or worse, a possible business shutdown. Compliance Architects® can provide the leadership, resources and methodology to ensure your next inspection isn’t your last inspection.
Serving the pharmaceutical, medical device, biologics, cosmetic, dietary supplement and food industries, Compliance Architects® understands that it takes a diverse set of interrelated capabilities to weave tightly integrated, optimally functional compliance infrastructures and maintain them at peak operating efficiency.
Compliance Architects® offers a comprehensive suite of professional advisory and consulting services specifically designed and developed to resolve the most common and challenging FDA compliance issues.
Compliance Architects® is proud to share with our potential clients and other interested parties a listing of our success stories and case studies to demonstrate how we solve significant business challenges for FDA-regulated companies.