QbDVision for Pre-Commercial
Move faster to market
Structure and connect your CMC knowledge in a platform that accelerates the translation to commercial manufacturing.
Streamline scale-up, transfer, and submissions
Cut tech transfer timelines
Create a live, shared digital model for transfer that captures product, process, and analytical procedure knowledge and accelerates alignment between teams.
Demonstrate process understanding
Demonstrate robust process understanding and control based on knowledge and Quality Risk Management.
Streamline regulatory submissions
Create a single source of truth for development knowledge to streamline regulatory submissions.
Overview
Accelerate the translation to commercial manufacturing
QbDVision enables pre-commercial teams to accelerate the translation to commercial manufacturing. The platform creates a single source of truth for CMC knowledge and its rationale, streamlining scale-up, tech transfer, and regulatory submissions.
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’re here to help you deliver
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