Analytical Method Validation (AMV)
We deliver robust, ICH-compliant analytical method validation services ensuring accuracy, precision, reproducibility, and regulatory acceptance for pharmaceutical products.
Our Capabilities
- Assay Method Validation (HPLC / GC)
- Dissolution Method Validation
- Related Substances & Impurity Profiling
- Chiral Method Validation
- Residual Solvent Analysis (GC-Based)
- Preservative Content Validation
Validation Parameters
- Accuracy & Precision
- Specificity & Selectivity
- Linearity & Range
- LOD & LOQ
- Robustness & Ruggedness
Regulatory Compliance
All validation studies follow ICH Q2 (R1/R2) guidelines ensuring global regulatory acceptance.
Advanced Instrumentation
High-performance analytical systems including HPLC, GC, and advanced detectors for precise results.
End-to-End Support
From method development to validation reports and regulatory submission support.