Pharmaceutical Over-Encapsulation Manufacturing

The contract entails the manufacturing of over-encapsulated pregnenolone and placebo tablets for a double-blind clinical trial, requiring strict adherence to current Good Manufacturing Practices (cGMP) throughout all stages, including formulation, encapsulation, and final packaging. The work must ensure product integrity, blinding integrity, and consistency to support valid clinical outcomes, with all processes documented and validated to meet regulatory standards. The manufacturer is responsible for supplying fully characterized, stable, and properly labeled tablet units compliant with the trial’s scientific and regulatory requirements. This subcontract is issued under the Department of Veterans Affairs, specifically by the 246-NETWORK Contracting Office 6, with a NAICS code of 325412 indicating pharmaceutical preparation manufacturing. The opportunity was posted on July 28, 2026, and responses are due by August 7, 2026, at 2:00 PM. While details regarding the place of performance, point of contact, or set-aside status are not specified, the scope centers exclusively on the production of clinical trial materials under controlled, auditable conditions suitable for use in regulatory submissions. No additional provisions or set-asides are indicated, suggesting the contract is open to qualified vendors meeting cGMP and trial-specific protocol demands.