Services

regulatory affairs pharma

                   R&D            

  • Formulation development (oral, sterile, topical, controlled release)
  • Process development and optimization
  • Scale-up and technology transfer

  • Troubleshooting complex formulation challenges

market access healthcare

GMP & Quality Systems

  • GMP audit 
  • SOP development and quality systems implementation
  • CAPA, deviation, and change control systems
  • Inspection preparation and support
  • CMC & regulatory strategy
quality compliance pharma

Facility & Manufacturing Advisory

  • Pharmaceutical facility design and setup
  • Manufacturing strategy and process flow design
  • CDMO selection and oversight
  • Tech transfer and commercial readiness