KALEO, INC.

KALEO, INC. specializes in the development and manufacturing of pharmaceutical preparations and biotechnology-driven medical devices, with a focused expertise in novel drug delivery systems and regulatory-compliant production processes. The company has demonstrated technical proficiency in the formulation and scale-up of critical-care injectables, including naloxone and pralidoxime chloride, and has successfully engineered auto-injector devices designed for rapid, reliable administration in emergency settings. Their work integrates pharmaceutical manufacturing standards with device innovation, ensuring compliance with FDA cGMP guidelines and NDC labeling requirements. KALEO’s ability to navigate complex regulatory pathways for both drug substances and combination products positions them as a niche provider in the intersection of pharmaceuticals and medical device development. The contractor maintains a strong working relationship with the Department of Veterans Affairs, delivering essential medications and addressing administrative corrections to drug product identifiers, indicating deep familiarity with VA’s supply chain and formulary management systems. They also support the Department of Health and Human Services on advanced biotech R&D initiatives, particularly in the design of next-generation antidote delivery platforms, reflecting their capacity to engage in mission-critical public health innovation. KALEO’s primary industry focus lies in NAICS 325412 (pharmaceutical preparation manufacturing) and 541714 (biotechnology research and development), where they bridge laboratory-scale innovation with commercial-scale production. Their specialization in antidote and emergency response therapeutics aligns them with federal preparedness and veteran healthcare priorities. As a small business structured as a 2L entity based in Richmond, Virginia, KALEO operates without federal certifications but leverages technical precision and regulatory agility to serve high-stakes government health missions. Their geographic presence and focused capabilities make them a trusted partner for agencies requiring reliable, compliant pharmaceutical and biotech solutions.