SHABAS SOLUTIONS LLC

Shabas Solutions LLC specializes in providing high-level scientific and administrative consulting services to federal agencies, with deep expertise in pharmaceutical development, chemistry, manufacturing, and controls (CMC), and digital health integration. The firm delivers subject matter expert support in biologics and small-molecule formulation, regulatory guidance for investigational new drugs, and laboratory logistics management, ensuring compliance with FDA and HHS standards. Their technical capabilities span end-to-end CMC strategy, clinical outcome assessment using digital health technologies, quality assurance frameworks, and scientific documentation for complex therapeutic pipelines. A key differentiator is their focused proficiency in bridging regulatory science with operational execution, particularly in supporting the biopharmaceutical lifecycle from early development through clinical evaluation. The contractor maintains a dominant presence with the Department of Health and Human Services, where they consistently support critical missions within FDA, NIH, and CDC components. Their work includes advising on biologics approval pathways, pharmaceutical formulation challenges, and the incorporation of digital health tools into clinical trial design—establishing a pattern of sustained, mission-critical engagement centered on public health innovation. Shabas Solutions primarily operates under NAICS 541611 (administrative management consulting) and 541990 (other professional scientific services), reflecting their role as a strategic advisor in regulated science environments. They specialize in the biopharmaceutical and life sciences vertical, offering tailored consulting that aligns with FDA guidance, GMP compliance, and clinical trial modernization initiatives. As a Women-Owned Small Business certified under the SBA’s WOSB program, Shabas Solutions leverages its certification to serve as a trusted partner in federal procurement ecosystems. Based in Fairfax, Virginia, the firm is strategically positioned to support federal science and health missions with agile, expert-led teams focused on regulatory excellence and operational integrity.