Independent analytical support—precise, fast, and regulatory‑ready
Our analytical laboratories support customers with focused, high‑impact assignments—from targeted investigations to full characterization packages—delivered with speed, clarity, and compliance.
Method Services
Development, transfer, qualification, and validation of analytical methods according to ICH expectations, including stability‑indicating and impurity‑focused assays.
Characterization & Profiling
Structural elucidation (MS, NMR), impurity identification, forced degradation studies, reference standard qualification, and deep profiling of complex impurity landscapes.
Impurity Isolation
Isolation and enrichment of impurities—major, minor, or trace—using preparative chromatography, crystallization, or tailored purification tools. Enables structural confirmation, impurity specification setting, and improved process understanding.
PGI & PMI Method Development (to ppm levels)
Specialized development of analytical methods for Potential Genotoxic Impurities (PGIs) and Potentially Mutagenic Impurities (PMIs) down to ppm‑level sensitivity. This includes targeted LC–MS/MS methods, selective sample preparation strategies, and validation packages aligned with regulatory expectations for genotoxic risk assessment.
Release & Stability Testing
GMP release testing and ICH‑aligned stability studies with trending, review, and clear, audit‑ready reporting.
Regulatory & Data Integrity
Phase‑appropriate documentation and complete data‑integrity compliance ensure reliable, submission‑ready results.