Product Development

   

Our expertise in quality matters will help you identify and overcome early challenges in your development journey.

  • Development plans
  • Analysis of the competitive landscape
  • Selection of raw materials suppliers and specialised GMP, GLP and GCP compliant service providers
  • Drug substance and drug product optimisation
  • ASMF/DMF review and preparation support
  • Quality and Non-clinical gap analysis
  • Quality and Non-Clinical study protocol design
  • Manufacturing process development and optimisation
  • Report writing