TQIP
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503B-outsourcing-One, an FDA-registered compounding pharmacy with DEA and cGMP facility registrations, serving hospitals, ASCs, and clinics nationwide. TQIP (Top Quality is Priority) is our operational cornerstone.
Market and Regulatory Drivers
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TQIP ensures sterility, potency, and compliance
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cGMP-level protection and traceability
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$2 Billion U.S. 503B market
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Strict FDA regulations = high entry barriers
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Demand from GPOs, IDNs, and hospital systems
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Growing need for reliable sterile suppliers
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Increase batch output + initial national distribution
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Add 300+ GPO/IDN partnerships
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Achieve 50-state licensure
Strategic Acquisition
Licensing Milestones
Contract Expansion
Scale Production
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One of out top priorities for 2027 is to build a 30 thousand sq. ft. facility in rural Florida with focus on training local people to work in a sterile environments and also paying it forward by employing locals to work in our facility.
A Deeper Dive
TQIP is dedicated to total quality assurance in every sterile medication produced:
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Compliance – Adhering to FDA 503B requirements and cGMP
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Safety – Strict sterility, environmental, and end-product testing protocols
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Reliability – Ensuring consistent high quality, potency, and dosage accuracy
Each batch undergoes potency,
sterility, and endotoxin testing
Following validated manufacturing procedures and strict quality controls
Ongoing tracking and assessment of production environments
Operating in ISO-8 classified
cleanrooms to maintain aseptic conditions
A Certificate of Analysis (COA) is a document provided to verify that a product meets specifications and quality standards. It includes:
Including sterility and endotoxin data
Quality assurance signature and date
Name, batch number, BUD (Beyond-Use Date)
TQIP-Powered. TQIP-Driven
