Performance CRO
Convert real product microstructure into physics-based digital twins that simulate drug release and manufacturing behavior, supporting smarter early- and late-stage decisions.
Who this is for
Teams that already understand the importance of microstructure and now need to predict performance, reduce risk, and guide development decisions with confidence.
Ideal Timing
Performance CRO is most valuable during early development when material and budget are limited, while narrowing formulation and process options, and when planning scale-up or preparing Q3, NDA/ANDA, or tech-transfer packages, especially when reducing reliance on long, expensive physical experiments is critical.
Business Outcomes
Scientific Workflow
Provide real product microstructure digital twins, computational representations built from imaging and quantified structure. DigiM predicts drug release and manufacturing scenarios to inform early- and late-stage decisions.
Microstructure Analysis
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In-silico Modeling
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Performance and Manufacturing Prediction
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Signature Modules
Formulation Optimization
Use microstructure-informed quality-by-design to efficiently narrow formulation space and accelerate development timelines.
Microstructure Performance Prediction
Apply digital twins and computational physics to predict in vitro and in vivo release performance with greater precision.
Microstructure Sameness
Evaluate structural equivalence by design to support ANDA, SUPAC, and bioequivalence strategies.
Process Optimization
Identify process conditions that reduce dissolution failures and batch-to-batch variability across sites.
Transform Your Program with Microstructure Science
Get started with a drug product digital twin.
