research and development

About Research & Development

Galentic R&D Centre at MIDC, Andheri (East) in Mumbai, is spread over 5000 sq. ft., focusing on development of sterile ophthalmic & topical dermatological products.

Our R&D capabilities include pre-formulation and formulation development, analytical development and validation, characterization, microbiology and In-vitro release testing (IVRT).

Our R&D Center has been recognized by Department of Scientific and Industrial Research (DSIR), Govt. of India.

Quality Management System (QMS) is in place for monitoring development work until successful technology transfer at GMP site.

Formulation Development

  • Pre-formulation and Physicochemical characterization
  • QbD based Formulation design and development
  • Process development and optimization
  • Lab-scale and feasibility batch manufacturing
  • ISO class 6 for Sterile manufacturing
  • Stability studies (ICH conditions for zone II and IVa & IVb)
  • Technology transfer to GMP site

Analytical Development

  • Analytical method development and validation of:
    • Assay of Active Pharmaceutical Ingredient and preservative
    • Related substances
  • Residual solvent testing
  • Reverse Engineering studies
  • Forced degradation studies (finished product)
  • Analytical method transfer to GMP site
  • 21 CFR compliant HPLC and GC systems linked to client server based software


  • Environmental monitoring
  • Microbiological Assay
  • Microbial Limit Test (MLT)
  • Preservative Effectiveness Test (PET)
  • Sterility – API, Excipient, Finished Product
  • Media preparation
  • Water analysis


  • Analytical method development in accordance with Bioanalytical method guidance
  • Analytical method validation for quantification of analyte
  • IVRT method development and validation
  • IVRT comparison study
  • Automated IVRT apparatus for faster and error-free results