Capabilities · CDO Platform
From pre-formulation to regulator-ready dossier.
An integrated CDO platform spanning formulation development, analytical method science, stability, and regulatory submission — purpose-built for complex molecules.
01
Formulation Development
From concept to scalable product.
Three dosage-form platforms · sixteen formulation & delivery
technologies · sixteen R&D manufacturing systems. Quality-by-Design execution across oral solids,
liquids, and sterile formats.
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02
Analytical Development
Method science that holds up to scrutiny.
AQS unit — physicochemical testing, method development & validation,
stability, and method transfer. Eight Shimadzu HPLCs, five stability chambers, full-spectrum supporting
analytics.
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03
Quality Assurance
Risk-based QMS at the core.
AQA unit — fully risk-based Quality Management System engineered to
clear regulator review with minimum cycles. cGLP discipline, CAPA, change control, document control, and
stability oversight.
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