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Method development, validation (ICH Q2(R2)) and transfer, release & stability testing, and impurity profiling—delivered by an experienced team using a wide range of techniques.
Lifecycle approach aligned with ICH Q2(R2); protocols, reports and data packages.
IPC and final release testing, real‑time/accelerated stability, retain management.
Impurity profiling, residual solvents, trace elements and structure elucidation.
Scope, target analytes, matrices, specs and timelines; NDA as required.
Method strategy, screening and optimization (DoE where appropriate).
Stage‑appropriate validation per ICH Q2(R2); protocol & report.
Tech transfer with comparability; training and documentation.
High-precision analysis for purity, identity, and chiral separation.
Sensitive detection of volatile and residual solvent impurities.
Advanced mass spectrometry for structural confirmation and trace analysis.
Rapid functional group identification and optical characterization.
Detailed molecular structure elucidation and purity assessment.
Accurate determination of trace moisture content in samples.
