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Analytical expertise plays a critical role in understanding product quality, process performance, impurity profiles, and stability throughout development and manufacturing. Reliable analytical data enables informed decision-making, supports regulatory expectations, and helps establish confidence in product quality.
Our analytical scientists work closely with development, manufacturing, quality, and regulatory teams to generate the insights needed to support process development, technology transfer, product release, and commercialization.
Addressing analytical challenges requires a combination of scientific expertise, advanced instrumentation, and robust methodologies. Our capabilities are designed to generate the data and insights needed to support development, manufacturing, and regulatory decision-making.
We develop phase-appropriate analytical methods for APIs, intermediates, peptides, and related substances to support process development, manufacturing, quality control, and commercialization. Analytical strategies are designed around the specific requirements of the development stage and molecule type.
Validated analytical methods establish reliable and reproducible performance that supports product quality, process understanding, and regulatory compliance. Validation activities are aligned with applicable regulatory expectations and industry guidelines.
Robust analytical development requires complementary techniques capable of addressing identity, purity, composition, stability, and performance questions.
Whether you're developing a complex small molecule, peptide API, intermediate, or new chemical entity, our analytical teams can help generate the insights needed to support critical development, manufacturing, and regulatory decisions.
Quick answers to help you better understand our CDMO capabilities and approach.
Still Have Questions? Contact UsAnalytical expertise provides the data needed to understand product identity, purity, stability, impurity profiles, and quality throughout development and manufacturing. It supports process development, product release, regulatory submissions, and commercial supply activities.
Analytical capabilities support small molecules, peptide APIs, intermediates, related substances, and new chemical entities throughout development and commercialization.
Services include analytical method development, validation, impurity profiling, characterization, stability studies, reference-standard investigations, and method transfer support.
Analytical methods generate the quality, impurity, stability, and characterization data needed to support regulatory documentation, compliance activities, and product approval processes.
Yes. Analytical activities continue beyond development and support quality control, stability monitoring, investigations, lifecycle management, and ongoing manufacturing activities.
Our teams investigate process-related impurities, degradation products, residual solvents, elemental impurities, nitrosamines, and low-level impurities that may impact product quality or regulatory requirements.
We conduct accelerated, long-term, and forced-degradation studies to evaluate product stability and support shelf-life determination, storage conditions, and lifecycle management activities.
Where reference standards are unavailable, we support targeted investigations to identify and characterize unknown materials, impurities, degradation products, moisture content, and other critical quality attributes.
These techniques support assay determination, impurity profiling, stability assessment, and release testing activities.
These methods support impurity identification, molecular characterization, and detailed analytical investigations.
These analytical tools support material characterization and understanding of critical product attributes.
These capabilities support elemental impurity evaluation and physical characterization requirements.
