Biomedical Product Development

 
 
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Biomedical Product Development

Leidos applies expertise in biomedical science to speed the discovery, development, and licensure of safe and effective medical treatments.

Our scientists boast deep domain knowledge in a variety of disciplines such as molecular biology, immunology, biochemistry, toxicology, pharmacology, psychology, program management, regulatory affairs, biosafety, environmental compliance, and more.

Leidos services span the full spectrum of the biomedical product life-cycle, from discovery through post-marketing surveillance. We deliver program management support for major biomedical research programs, including planning and portfolio review, process development, and project management. We apply our in-depth knowledge of the U.S. Food and Drug Administration's (FDA) regulatory process to help prepare products for rigorous FDA evaluation, and we work with manufacturers to assure quality and compliance with current Good Manufacturing Practices (GMPs)*.

With effective management, careful planning, and expert scientific and technical personnel, Leidos helps clients get the results they need.

Our biomedical product life-cycle development support services include:

  • Program management
  • Concept project/product development strategies
  • Laboratory research/candidate discovery
  • Bench to GMP transition
  • Preclinical development and safety testing
  • Regulatory compliance and acquisition support
  • Biotechnology quality assurance and compliance consulting

For more information visit the FDA Pharmaceutical Quality/Manufacturing Standards (CGMP).

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For more information about our business solutions and capabilities, contact us today.