Focused on the business of compounded medications
including pharmacy and physician compounders (503A), FDA registered outsourcing facilities (503B), and pharmaceutical manufacturers (CMO)
503QM was created by industry experts with decades of experience in the business of drug compounding because there was no single source of accurate and usable information for all corners of this space. 503QM has aligned with numerous subject matter experts (SMEs) in a variety of pertinent areas such as HVAC / critical airflows, cGMP & USP compliance, process validation, quality assurance / quality control, mergers & acquisitions, and healthcare regulation and we provide our clients with project teams designed to meet their specific needs.
Whether you need to create a new medication compounding business, acquire or expand an existing business, or respond to a problematic regulatory inspection (State Board of Pharmacy or FDA) 503QM can provide you the expert guidance to achieve your desired outcomes. Please contact us to discuss your needs and explore how 503QM can assist you.