ASSURED BIO LABS, LLC

Assured Bio Labs, LLC specializes in aseptic environmental and microbiological testing services for pharmaceutical and healthcare operations, with deep expertise in USP <797> and USP <800> compliance, media fill testing, fingertip glove sampling, and pharmaceutical compounding hood validation. The company delivers laboratory services that ensure sterility assurance and personnel competency in cleanroom environments, supporting the integrity of compounded sterile preparations. Their technical capabilities include environmental monitoring, microbial identification, contamination control assessments, and aseptic technique evaluation—critical for maintaining FDA and USP standards in high-risk compounding areas. Assured Bio Labs distinguishes itself through precision-focused, regulatory-aligned testing protocols tailored to the stringent demands of institutional pharmacy operations. The contractor maintains a consistent and primary relationship with the Department of Veterans Affairs, delivering laboratory testing services across multiple VA healthcare systems to support pharmacy safety, personnel certification, and environmental compliance. Their work for the VA centers on sustaining aseptic compounding programs through recurring, mission-critical testing cycles. A single engagement with the Department of Health and Human Services further demonstrates their capacity to support federal pharmacy vendor oversight and quality assurance initiatives. Assured Bio Labs operates primarily under NAICS 541380 (Testing Laboratories and Services) and 621511 (Medical Laboratories), positioning itself as a niche provider in pharmaceutical and clinical laboratory services for government health systems. Their focus is squarely on aseptic processing validation, microbial quality control, and compliance testing—serving the specialized needs of institutional pharmacies, sterile compounding centers, and healthcare facilities requiring regulatory adherence. As a Women-Owned Small Business and Woman-Owned Business certified firm based in Oak Ridge, Tennessee, Assured Bio Labs brings a compliance-driven, mission-focused approach to federal contracting. Their certification status enhances their eligibility for targeted set-asides, and their geographic location supports timely service delivery to federal medical facilities across the eastern and western United States.