CMC Product development

Product development : Supporting the development of the best 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, patentability), process (scale-up, validation, manufacturing strategy)
    • Analytical development (development, validations and transfer, gap analysis, specifications)
    • Stability studies (design, trend analysis, setting of shelf life)
  • Project management : coordination of all activities in pharmaceutical development from API selection, product development, clinical supplies, transfer to CMO, to registration and geographical roll out, including CMOs and CROs management
  • Decision making to drive investments: Due diligence, gap analysis and experts reviews
North Texas Medical Center Pharmacology