QbDVision for Clinical
Move faster through clinical development to regulatory
Structure and connect your CMC knowledge in a platform that enables you to maintain robust process development and understanding as programs mature.
Manage increasing complexity as your programs scale up and out
Maintain traceability
Execute your development roadmap using QbD-based best practices.
Ensure consistent knowledge across sites
Centralize your CMC knowledge to simplify CDMO interactions and clinical phase tech transfers.
Support regulatory readiness
Capture clinical development knowledge with data-backed justifications as required by ICH.
Overview
Confidently manage CMC knowledge
QbDVision enables clinical teams to confidently manage CMC knowledge as programs mature. The platform creates a single source of truth for CMC data and its rationale, ensuring robust process design, reliable and compliant tech transfer, and consistent regulatory readiness.
Process design maturation
Ensure that your process is robust, controlled, and scalable
Manage process changes without losing rationale.
Confirm your design space through experimentation.
Define CQAs and CPPs and establish their acceptance criteria and control ranges to ensure product quality.
Tech transfer enablement
Enable reliable, compliant tech transfer
Digitally transfer process definitions along with critical context to maintain process intent and product quality.
View side-by-side analysis of process elements across sites to identify gaps and risks in parameters, quality attributes, materials, and equipment.
Work from a single, governed source of truth to focus on analyzing changes instead of gathering and consolidating data.
Development knowledge capture and reuse
Maintain traceability for regulatory readiness
Trace relationships from product quality attributes and ATP requirements through Performance Characteristics, Analytical Procedure Attributes, Materials, and Procedure Parameters.
Easily access previous versions of records that may be needed for submissions.
Generate documentation using your live CMC data.
Real-world impact for CMC teams
60%
reduction in time to perform process risk assessments and generate an FMEA report
50%
reduction in time to perform process definition gap assessment during tech transfer
$600K
reduction in annual costs per clinical manufacturing site
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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