Ensuring Product Safety, Efficacy, and Consistency
Analytical Chemistry forms the scientific foundation of product quality assurance in pharmaceuticals and medical devices. It ensures the chemical integrity, potency, and safety of all products — from API synthesis to final dosage form — in accordance with global GMP and ICH standards.
Our GMP/GLP-compliant laboratories utilize advanced HPLC, GC-MS, LC-MS/MS, NMR, FTIR, and UV-Vis platforms to provide quantitative and qualitative data for product release and regulatory submission. Each method is developed and validated to deliver precise, reproducible, and traceable results.
BQCIS supports clients from method development and impurity profiling to forced degradation and stability testing — providing the scientific evidence needed to meet global regulatory expectations and accelerate product-to-market timelines.
Key Analytical Services
Key Benefits of Analytical Chemistry
Ensure Data Integrity & Traceability
All analyses are conducted under ALCOA+ principles — ensuring that results are attributable, legible, contemporaneous, and audit-ready.
Support Global Regulatory Submissions
Provides scientifically defensible data packages for FDA, EMA, and WHO submissions, accelerating product registration.
Strengthen Product Quality & Consistency
Verifies chemical uniformity and stability, minimizing batch variability and ensuring consistent therapeutic performance.
Accelerate Development Timelines
Optimized methods shorten turnaround time for characterization and validation — expediting clinical and commercial release.
Success Story
Structural Elucidation Resolves API Impurity Crisis
A pharmaceutical client identified an unexpected impurity spike during routine stability testing, halting release of a key API batch.
BQCIS developed a rapid analytical workflow using HRMS and NMR to isolate and elucidate the impurity structure. The compound was traced to a solvent degradation pathway, verified through comparative reference standard testing.
The client successfully adjusted their process, completed regulatory justification, and resumed production within one week — avoiding costly recall and maintaining uninterrupted global supply.