Regulatory & Translational Strategy Consulting

The contract involves providing specialized advisory services to support the development of a gene therapy product through IND-enabling activities, with a focus on regulatory planning, safety and toxicology study design, and the strategic transition to GMP-compliant manufacturing processes. The work requires deep expertise in navigating regulatory pathways for advanced therapeutic products and ensuring that preclinical data packages meet FDA expectations for investigational new drug applications. Services will be delivered under a subcontract arrangement with the National Institutes of Health under the Department of Health and Human Services, and the effort is categorized under NAICS code 813920 for other technical and trade schools, indicating a specialized consultancy nature. The solicitation was posted on June 30, 2026, and responses are due by July 9, 2026, with no specific location for performance identified, allowing for remote or distributed delivery. There is no set-aside designation specified, meaning eligibility is open to all qualified entities. The advisory work is critical to bridging preclinical development and clinical initiation, requiring alignment between scientific rigor and regulatory compliance to de-risk the gene therapy program’s progression.