At Abiozen, method development and validation form the cornerstone of reliable pharmaceutical analysis, ensuring that every product is accurately characterized for identity, potency, purity, and stability. Our analytical solutions are designed to support regulatory compliance and global scalability across the product lifecycle.

Custom Assay Development

We specialize in designing bespoke analytical assays that assess critical quality attributes unique to each product. Using cutting-edge technologies—including high-performance liquid chromatography (HPLC), gas chromatography (GC), and mass spectrometry (MS)—we develop methods with exceptional sensitivity and specificity. These assays are purpose-built for active pharmaceutical ingredients (APIs), biologics, and finished formulations, enabling precise characterization and control.

ICH Q2-Compliant Method Validation

Our validation protocols strictly adhere to International Council for Harmonisation (ICH) Q2 guidelines. We evaluate analytical methods across all critical parameters, including accuracy, precision, specificity, detection limit, quantitation limit, linearity, and robustness. This ensures that each method is scientifically sound, fit for its intended use, and fully suitable for regulatory submission and product approval across global markets.

Analytical Method Transfers

To support multi-site operations and contract manufacturing models, Abiozen offers robust analytical method transfer services. This includes method equivalency assessments, performance verification, and documentation to ensure seamless execution across laboratories and production sites. Our rigorous transfer protocols reduce variability, enhance reproducibility, and mitigate risk—ensuring continuity and compliance throughout the supply chain.

Industry Alignment

Inspired by best-in-class practices from Curia Global and Thermo Fisher Patheon, Abiozen models its method development framework to support complex molecules, high-potency APIs, and CDMO integrations. Our scientific rigor and regulatory foresight position us as a trusted partner for analytical method innovation and lifecycle support.