QbDVision for Preclinical
Move faster to first-in-human
Structure and connect your development knowledge in a platform that enables you to move faster to IND submission.
Set up scalable, compliant workflows from day one
Establish clear product requirements
Create a product quality profile to ensure product efficacy and patient safety.
Accelerate IND preparation
Organize your CMC data to accelerate IND preparation and minimize risks of IND clinical hold due to CMC deficiencies.
Establish sound data governance
Establish sound data governance and integrity practices early in development.
Overview
Integrate quality from the start
QbDVision enables preclinical teams to integrate quality into their products and processes from the start. Structuring and contextualizing CMC data streamlines collaboration, accelerates regulatory submission, and creates a trusted foundation for AI, allowing you to move faster to first-in-human with confidence.
Process and product feasibility
Establish your product and process concept
Define your initial process intent and structure.
Capture assumptions, decisions, and rationale as development evolves.
Explore feasible operating ranges and early hypotheses.
Utilize your structured data to create a coherent story of development intent without locking into final formats.
Early risk identification and prioritization
Identify and prioritize quality and process risks
Identify, score, and prioritize CQAs, CPPs, and failure modes.
Link risk to mitigation strategies and experiments.
Keep early risk rationale available downstream.
Development knowledge capture and reuse
Structure R&D knowledge that can be reused later
Create a centralized development knowledge repository that can be reused for future projects.
Maintain traceability across experiments, decisions, and outcomes.
View full version history to see how knowledge evolved throughout a project.
Generate reports that contain development history and rationale.
Real-world impact for CMC teams
45%
reduction in time to perform and author risk assessment documents
60%
reduction in time to perform process risk assessments and generate an FMEA report
30%
reduction in time to perform historical trend analysis
Beyond Implementation
Our people-first approach
We partner with pharma, biotech, and CDMO teams to build a platform that captures structured CMC data, preserves process knowledge, and maintains continuity across the full development lifecycle.
We’re here to help you deliver
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