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, from FDA Consent Decrees and Warning Letters to EU MDR transitions and supplier quality remediation. We combine deep technical expertise with a proven talent delivery model, giving our clients both the strategic guidance and the skilled people needed to execute.
Our consultants and placed professionals bring direct, hands-on experience inside regulated manufacturing environments, not just advisory theory. That combination of regulatory depth and operational reality is what allows us to deliver results other consultancies can't.
Explore Our Services
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.
We measure our success not just in projects completed, but in consent decrees lifted, inspections passed without observation, and quality systems strengthened for the long term.
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 →“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.”
“We engaged Ragan Consulting Solutions to lead our complaint handling and PMS remediation while simultaneously standing up a program management office to coordinate across six concurrent workstreams. They delivered both. Their SMEs brought deep regulatory knowledge, and their program management discipline kept everything on schedule, on budget, and visible to leadership. A rare combination in this industry.”
