Technical Documentation Support for Drug Manufacturing Quality Assurance

The Office of Manufacturing Quality within the Food and Drug Administration is seeking technical documentation support to manage its increasing volume of critical regulatory communications, having issued 87 warning letters through the third quarter of FY25 and projecting over 110 by fiscal year end. This effort requires specialized editorial and technical writing services to ensure high-quality, consistent, and compliant documentation that meets regulatory standards. Professional editing services will standardize terminology, style, and formatting across all manufacturing quality documents, directly improving clarity, credibility, and regulatory acceptability of submissions and compliance materials. The contract will provide expert review to detect and correct technical inaccuracies, grammatical errors, and formatting inconsistencies that could undermine the integrity of official communications or delay regulatory approvals. Services are intended to support the operational demands of the agency’s drug manufacturing quality assurance functions, with all work performed to align with FDA’s stringent requirements. The procurement is forecasted under NAICS code 541611 for scientific and technical consulting services, with point of contact information provided through the FDA’s CDER Acquisition Liaison, and the contracting officer role pending assignment. The opportunity is publicly listed on the OSDBU portal for contractor visibility and engagement.