Sathi-USBio Consulting provides scientific expertise and on-site services for small biopharma and start-ups to help fill their gaps in bioanalytical and preclinical testing efforts and accelerate product development towards IND/phase 1 clinical trial stage.
Specific expertise include: development, validation and transfer of GxP bioanalytical assays, cell-based assays and bioassays; pharmacokinetic analysis, immunogenicity assessment and biomarker analysis; preclinical study analysis; GxP laboratory set-up; regulatory compliance and writing/review of regulatory documents
Sathi-USBio is committed to provide dedicated and cost-effective consulting services to meet specific needs of your projects. Our mission is to provide customer focused real-time on-site support including hands-on work as needed, staff training, data analysis, project management and timely problem solving to keep your project progress on-track and meet timelines. We will effectively communicate and work with different departments / staff teams at your site and with external CROs, and manage/implement your projects successfully by means of efficient resource and work-flow management, failsafe and backup strategies and timely execution of tasks.