Analytical Method Validation US FDA Certified

Analytical Method Development:
  • Raw Material & Intermediate Release
  • API and Drug Product Release
  • ICH Stability Studies
In-process testing method development for reaction monitoring
Phase-based Approach to Analytical Method Qualification & Validation as per US FDA
  • Assay
  • Related substances
  • Residual solvents
  • Forced Degradation Studies
API Release Testing and Certificate of Analysis
Impurity Isolation and Characterization
Reference Standards Certification and Management
ICH Stability Studies for API and Finished Product to Support Development, Clinical Study, and Commercial Manufacturing