FDA Consulting for Medical Devices, Pharma, Software and Biologics
ACHIEVING QUALITY
OUR MISSION:
We specialize in providing comprehensive FDA compliance services tailored to the pharmaceutical, medical device, and biologics industries. Our expertise includes guiding clients through FDA readiness processes and delivering strategic remediation for complex compliance challenges.
OUR SERVICES:
Strategic Compliance Services LLC encompass a wide range of quality and compliance solutions, including mock audits, compliance verification, due diligence audits, third-party reviews, internal audits, and the development and implementation of robust quality systems. We also perform gap analyses and provide support for MDSAP, EU MDR, and FDA responses and correspondence. In addition to consulting services, we offer customized training programs designed to enhance the expertise and capabilities of staff at all levels. These programs cover essential topics such as Corrective and Preventive Actions (CAPA), investigations, design control, risk management, software compliance, and complaints handling, among others. Each training is tailored to meet the specific needs of our clients, ensuring that their teams are equipped with the knowledge and skills required to maintain regulatory compliance.
By combining deep industry expertise with a proactive approach, we help our clients navigate regulatory complexities with confidence. Our goal is to empower organizations to establish and sustain high standards of quality and compliance, fostering long-term success and regulatory excellence.
About the Owner
Sean’s career is defined by his leadership in tackling complex challenges within the FDA regulatory landscape, but his personal life adds some delightful color to the picture. When he isn’t devising robust quality systems or providing actionable CAPA strategies, you might find him exploring a new corner of the globe, outsmarting opponents in his favorite games, or catering to the whims of his beloved feline companions. (Yes, Sean’s cats hold him to standards almost as high as the FDA’s.)
Whether he’s consulting on compliance matters or recounting an adventurous travel tale, Sean brings a unique mix of professionalism, relatability, and wit to every interaction. He’s not just an expert in regulatory affairs—he’s a strategist, "tell it as it is", get it done kind of guy with a knack for making the complex world of FDA compliance a little more approachable.
