QbD

QbD based Formulation Services

  • Pre-formulation profiling and druggability assessment
  • Generic formulation development
  • Formulation Development for EIH studies
  • Formulation Development for Phase 1b, POC, Phase II & Phase III
  • Preclinical Formulation Development
  • Formulation Development for Life Cycle Management
  • (LCM/NDDS)
  • Formulation Development for Life Cycle Management
  • Pediatric Formulation Development

Analytical Research & Development Services

  • Analytical method development for API and drug product
  • Method validation for API and drug product to support DMF/IND/CTA/NDA/ANDA applications
  • Stability studies to support development and regulatory fillings of API and drug product development
  • Solid state characterization for 'as is API' and in drug product.
  • Cleaning methods for drug products
  • Method transfers