Regulatory Strategy and FDA Submissions

This contract involves developing a comprehensive regulatory strategy and preparing Investigational New Drug (IND) or Investigational Medicinal Product Dossier (IMPD) applications specifically for vaccine candidates. The contractor is responsible for coordinating with regulatory agencies such as the FDA and EMA to secure fast-track or pandemic-related designations, which are critical for expediting the development and approval process of vaccines. The work will be performed as a subcontract under the Department of Health and Human Services, with an anticipated focus on navigating complex regulatory pathways to facilitate timely submissions and approvals. The contract falls under the NAICS code 541690, indicating a focus on scientific research and development services. Although the solicitation number and specific organization type are not provided, the place of performance is Washington, D.C., with a response deadline set for mid-July 2026. The contract aims to support public health priorities through regulatory expertise, ensuring vaccine candidates move efficiently from development toward clinical trials and potential emergency use authorizations, particularly during public health emergencies or pandemics.