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  1. FDA Recommended
  2. Truncate FDA approval time
  3. BIB’s QbD driven PC studies
  • Recommended by FDA for product approval
  • Significantly reduces time to FDA approval
  • Ensures that the process delivers a product with reproducible yields and purity
  • Deeper understanding of your product during commercialization
  • Define process design space
  • Justifies operating ranges and acceptance criteria
  • Minimize and aid in the investigation of deviations
  • Ensure product quality will not be impacted due to small operational variations
  • occurred within the manufacturing process
  • Identifies key operating and performance parameters
  • Offers Quality-by-Design driven PC studies
  • Years of valued experience in PC projects
  • Capability for scale-down modeling to 1L parallel platform for high
  • efficiency PC experiments
  • Upstream, downstream and analytical characterization capabilities