Clinical, regulatory, and quality leader Casey Hannan launches SoBo Clinical & Regulatory Advisory to help early-stage companies navigate FDA strategy, clinical development, and trial readiness.
Casey Hannan, a clinical, regulatory, and quality leader with over a decade of experience in FDA-regulated medical device development, has launched SoBo Clinical & Regulatory Advisory. Through her firm, Hannan will partner with emerging medtech and health tech companies to guide them through the complexities of clinical trials, regulatory strategy, and FDA readiness.
SoBo Clinical & Regulatory Advisory focuses on supporting early-stage and growth-stage companies developing innovative devices and therapies that often lack the internal infrastructure needed to successfully navigate clinical and regulatory pathways. Hannan’s work centers on helping these organizations build strong, compliant foundations early—ensuring they avoid costly delays and are fully prepared for FDA engagement.
Strategic Advisory Grounded in Operational Reality
As Founder and Principal Consultant, Hannan provides both strategic advisory and hands-on operational support. Her expertise spans clinical trial design and execution, development of standard operating procedures (SOPs), regulatory submissions, and preparation for FDA inspections and Q-submission meetings. She works closely with teams to align with FDA requirements, including 21 CFR guidelines, while maintaining a practical, execution-focused approach that enables companies to move forward with confidence.
A Dynamic Career at the Intersection of Academia & Industry
Hannan has built her career across both academic and industry settings, bringing a distinct perspective to her consulting work. She began in clinical research at Johns Hopkins University, where she managed clinical research programs and supported investigator-initiated and commercially-sponsored-studies—building a strong foundation in compliance, documentation, and clinical operations.
She later transitioned into the startup and medical device space, where she held leadership roles including Vice President of Clinical and Regulatory Affairs at CoolTech Medical and Mi-Helper, Inc. In these roles, she led regulatory strategy and clinical operations, often stepping into early-stage environments to build structures where none existed—from establishing SOPs and clinical frameworks to leading regulatory submissions and engaging directly with the FDA.
Local Roots, National Reach
While rooted in the Baltimore innovation ecosystem, Hannan is focused on supporting local companies while bringing the capability to work with clients across the country—combining close, on-the-ground engagement with the flexibility to scale her impact nationally.
In Her Own Words
“Launching SoBo Advisory is the right next step for me,” said Hannan. “It gives me the opportunity to apply what I’ve learned across different companies and therapeutic areas, while continuing to grow alongside the innovators I work with. I’m especially excited to partner with teams building meaningful technologies and help guide them through the clinical and regulatory process.”
Professional Background
Casey Hannan has built her career at the intersection of clinical research, regulatory strategy, and quality—developing a reputation for bringing structure and clarity to early-stage environments. With experience spanning both academic research and high-growth medical device companies, she has led clinical programs, regulatory submissions, and cross-functional initiatives critical to advancing products toward FDA clearance.
Prior to launching her firm, Hannan served as Vice President of Clinical and Regulatory Affairs at CoolTech Medical and Mi-Helper, Inc., where she guided clinical operations and regulatory strategy through key stages of development. Earlier in her career at Johns Hopkins University, she managed clinical research programs and helped establish the operational infrastructure needed to support them.
Known for her practical, steady approach, Hannan specializes in helping teams navigate complex regulatory requirements with a focus on data integrity, trial readiness, and long-term scalability. She holds a B.S. in Psychology and Neuroscience from the University of Maryland and is a certified clinical research professional (ACRP-CP).
About SoBo Clinical & Regulatory Advisory
SoBo Clinical & Regulatory Advisory is a consulting firm providing clinical research, regulatory strategy, and operational support to early-stage medtech and health tech companies. Founded by Casey Hannan, the firm helps organizations navigate FDA requirements, prepare for clinical trials, and build the infrastructure needed to bring innovative products to market. With a flexible, hands-on approach, SoBo partners with companies locally and globally to accelerate development and drive regulatory success in the US.
Work with Casey Hannan
Companies seeking experienced clinical and regulatory leadership are invited to connect with Casey directly at casey@soboadvisory.com.
