Structured Analytical Support Across
Pharmaceutical Development
Our Analytical Services provide comprehensive support for pharmaceutical development through method development,
physicochemical characterization, formulation support, stability and regulatory documentation.
Analytical activities are performed within controlled quality environments, with a strong focus on
data integrity, reproducibility, and regulatory alignment.
Analytical Capabilities Overview
Analytical studies are integral to understanding product quality and supporting development decisions throughout the lifecycle. Our analytical capabilities are designed to support API characterization, formulation development, stability studies, and regulatory submissions through scientifically rigorous and well-documented testing strategies.
Method Development & Validation
Design and validation of analytical methods supporting API characterization, formulation development, and release and stability testing.
Our analytical team develops and evaluates methods that are fit for purpose, stability-indicating, and aligned with regulatory expectations.
Key capabilities include:
- HPLC, UPLC, GC, LC–MS/MS, and ICP–MS method development
- Method validation in alignment with ICH Q2 (R2) and regulatory expectations
- Forced degradation and stability-indicating method development
- Dissolution and drug release method design for all dosage forms
- Biorelevant and discriminatory dissolution studies for oral products
Supports accurate product understanding and robust analytical control throughout the lifecycle.
Characterization & Physicochemical Analysis
Comprehensive analytical services supporting API and excipient characterization to enable developability assessment and informed formulation strategy.
Our analytical toolkit provides detailed insight into physical, chemical, and solid-state properties across development stages.
Our analytical toolkit includes:
- Spectroscopic techniques
- Thermal and physical property evaluation
- Moisture and residual solvent analysis
- Polymorphism and solid-state stability assessment
Supports a robust understanding of material behavior and solid-state properties throughout development.
Analytical Support for Formulation Development
Our analytical team works closely with formulation scientists to provide end-to-end analytical support throughout formulation development.
Analytical strategies are aligned with formulation design, process development, and quality requirements at each stage.
Key capabilities include:
- Prototype evaluation and release testing
- Compatibility and extractable/leachable studies
- Content uniformity, assay, and impurity profiling
- In-process controls and process validation support
Enables consistent formulation development supported by reliable and well-documented analytical data.
Our Analytical Approach
Quality-Focused and Development-Oriented
Our analytical approach emphasizes:
- Defined analytical strategies aligned with development goals
- Controlled workflows and traceable documentation
- Data integrity and regulatory readiness
- Cross-functional collaboration across development teams
This structured approach ensures analytical data is reliable, interpretable, and suitable for downstream decision-making.
Why Analytical Services Matter
Reliable analytical data underpins pharmaceutical development by supporting product understanding, quality control, and regulatory confidence. A structured analytical strategy reduces development risk, improves data consistency, and strengthens the foundation for formulation, stability, and manufacturing activities.
Looking for a Trusted Pharmaceutical Partner?
Let’s discuss how our pharmaceutical capabilities can support your requirements.