Supplier of Pediatric and Low-Dose Formulations

The contract seeks a supplier capable of providing low-dose medications in highly precise strengths specifically formulated for pediatric use or sensitive-dose research studies. These formulations must meet stringent quality and consistency standards to support clinical research requiring accurate dosing in vulnerable populations. The scope focuses on the production and delivery of specialized pharmaceutical products tailored to the unique needs of pediatric trials and pharmacological studies where standard dosing is inappropriate or unsafe. Submitted responses are due by May 15, 2026, at 6:00 PM, with the opportunity issued as a subcontract under the NAICS code 325412, which pertains to pharmaceutical preparation manufacturing. The contracting entity is the FDA Office of Acquisition and Grant Services under the Department of Health and Human Services. Though no set-aside provisions or location details are specified, the requirement demands rigorous adherence to pharmaceutical manufacturing controls and the ability to reliably produce small-volume, high-precision dosage forms. Interested parties must ensure compliance with regulatory expectations for pediatric drug development and submit proposals through the designated SAM.gov portal before the deadline.