De-risk drug development
At Crystal Bio Solutions, we integrate biometrics, pharmacometrics, and modeling & simulation to help development teams:
• Select safer and more efficient first-in-human doses, reducing early-phase risk.
• Design smarter adaptive and enrichment trials that maximize statistical power and resource use.
• Identify patient populations and endpoints most likely to demonstrate efficacy, accelerating proof-of-concept.
• Build quantitative evidence packages that strengthen briefing materials and regulatory submissions (IND, BLA, ICH).
Bioanalysis & Biomarkers
Design, develop and validate custom assays to be regulatory-ready from day 1
Clinical Pharmacology
Modelling and success prediction of your drug, translation to humans and dosing.
Chemical Manufacturing Control
Full molecule characterization and production at large scale.
Regulatory
Guidance and documentation for FDA submissions (IND, BLA, ICH).
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