FAST-TRACK DRUGS & BIOLOGICS, L.L.C.

FAST-TRACK DRUGS & BIOLOGICS, L.L.C. specializes in end-to-end contract research organization services for pharmaceutical and biologic development, with deep expertise in clinical data management, regulatory documentation, and protocol design for FDA submissions. The company provides tailored support for drug repurposing studies, including the design and execution of clinical trials for complex indications such as alcohol use disorder, while ensuring compliance with GCP, 21 CFR Part 11, and HIPAA standards. Their technical capabilities include secure clinical data management system updates, FDA information package preparation, protocol synopsis development, and integrated data analysis workflows that support accelerated regulatory review pathways. A key differentiator is their focus on bridging translational research with regulatory strategy, enabling sponsors to navigate complex approval processes with precision and speed. The contractor maintains a strong, consistent relationship with the Department of Health and Human Services, delivering specialized CRO services across its components, including NIH and FDA-aligned initiatives. Their work supports mission-critical drug development programs, particularly in behavioral health and neuropharmacology, where data integrity, audit readiness, and rapid turnaround are paramount. Operating under NAICS 541990, the firm is positioned as a niche provider of professional scientific services in the biopharmaceutical sector, focusing on non-clinical and clinical research support rather than broad laboratory testing or manufacturing. Their market positioning emphasizes agility, regulatory acumen, and domain-specific knowledge in CNS and addiction therapeutics. As a Women-Owned Small Business certified under the SBA’s 8(a) program and recognized as a Woman-Owned Business, FAST-TRACK DRUGS & BIOLOGICS, L.L.C. brings diverse leadership to the federal contracting landscape. Based in Poolesville, Maryland, the company leverages its proximity to federal science hubs to deliver responsive, compliant, and scientifically rigorous support to public health initiatives.