CMC Product development

Product development : Supporting the development of a succesful product while ensuring quality compliance

  • Strategic consultancy during global pharmaceutical development and lifecycle management
  • Expertise in all types of API (chemical, biological, herbals)
    • Development of ASMF, DMF, CEP 
    • Development of USP/EP monographs
  • Drug product development :
    • Formulation (development and patentability), process (scale-up, validation and manufacturing strategy)
    • Analytical development (development, validation and method transfer, gap analysis and specifications setting)
    • Stability studies (design, trend analysis and setting of shelf life)
  • Project management : coordination of all activities in pharmaceutical development from API selection, product development, clinical supplies and transfer to CMO; to registration and geographical roll out, including CMOs and CROs management
  • Decision making to drive investments: Due diligence, gap analysis and expert reviews
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