Specialized consulting and talent acquisition for Medical Device, Pharmaceutical & Biotechnology manufacturing, and other high-impact, regulated industries.
Ragan Consulting Solutions is a premier consulting and talent acquisition firm delivering specialized expertise across Life Sciences (Medical Device, Pharmaceutical & Biotechnology Manufacturing), Automotive, Aerospace, AI, and Software industries. With over four decades of combined experience partnering with global organizations, our subject matter experts help companies navigate complex regulatory challenges, remediate quality systems, and build the teams they need to succeed.
Our Mission & Commitment
Our mission is to be the premier partner for organizations seeking specialized consulting talent and strategic advisory services across regulated and high-technology industries. We are committed to delivering professionals of exceptional caliber who drive innovation, ensure compliance, and create lasting value.
Specialized support for CAPA programs and FDA Consent Decree or Warning Letter remediation.
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Strategic, credible response support when you've received an FDA Form 483 or Warning Letter.
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Establish and maintain robust supplier quality programs that meet ISO 13485 requirements.
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QMSR & ISO 13485 design control expertise spanning the full development lifecycle.
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ISO 14971 risk management programs built into your product lifecycle, not bolted on.
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Compliant complaint handling and post-market surveillance systems aligned to FDA, ISO 13485, and EU MDR.
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Process, equipment, and computer system validation aligned to FDA 21 CFR Part 820, ISO 13485, and GAMP 5.
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Quality and regulatory due diligence and integration support across the M&A lifecycle.
Read More →“Ragan Consulting Solutions has been an invaluable partner in our FDA remediation efforts. Their expertise in regulatory compliance, CAPA management, and quality systems helped us successfully navigate a consent decree and restore our operations ahead of schedule. Their team's professionalism and depth of knowledge are unmatched in the industry.”
“When we received a Warning Letter, we needed partners who understood both the regulatory stakes and the operational reality of a manufacturing environment. Ragan Consulting Solutions guided us through every CAPA, strengthened our design controls program, and helped us rebuild FDA confidence from the ground up. Their responsiveness and technical depth are unlike anything we've experienced with outside consultants.”
“Ragan Consulting Solutions delivered exactly what we needed at a critical moment. Their validation expertise, from IQ/OQ/PQ protocol development through CSV and 21 CFR Part 11 compliance, gave our team the structure and confidence to pass our FDA inspection without a single observation related to our systems. They didn't just execute the work, they transferred knowledge that made our internal team stronger.”
“Ragan Consulting Solutions played a decisive role in our Warning Letter response and the supplier quality remediation program that followed. Their risk management expertise helped us prioritize the right fixes in the right order, preventing further escalation while we worked through the broader systemic issues. The board had full confidence in the roadmap they built, and the results bore that out.”
North America, South America, Europe, APAC, and the Middle East. Our global recruiting model and remote-first delivery approach mean we can build dedicated teams that work together from anywhere in the world.
Contact UsLife Sciences, Automotive, Aerospace, AI & Software.
