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Quality Means Business

Welcome to

Provider of Global regulatory expertise for Medical Devices, Diagnostics, Biologics, Drug Delivery, Software as a Medical Device and Combination Products. â€‹

QMB provides advisory services for FDA and global regulatory matters. We assist with quality assurance, regulatory affairs, clinical operations, compliance, product submission clearances, and approvals. Our therapeutic specialties include orthopedics, drug delivery, capital equipment, diagnostic devices, and biologics to name a few. We strive to be collaborative partners with our clients in all engagements. 

Are you ready to accelerate the way you develop regulatory strategies and prepare for product submissions? We are developing QualiVerse®, a new AI platform that will help organizations rapidly assess regulatory pathways to clearances and approvals. 

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Connect with us to learn how we are utilizing technology and advances in AI to bring regulatory affairs into the 21st century.

We are the trusted partner of:

Consult with us for your RA and QA needs

We are here to assist. 

FDA and EMA Regulations • Quality Assurance • Regulatory Strategy • Quality Management Systems

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