CMC Product development

CMC Services – Chemistry, Manufacturing and Controls Product development : Supporting the development of a successful product while ensuring quality compliance

BlueReg has a dedicated team of CMC consultants with significant expertise in all areas of CMC development.

Our experts can advise you on pharmaceutical development strategy and provide oversight for the overall product development process to ensure key development milestones are successfully reached.

From early development phases to registration, we ensure CMC regulatory compliance for your projects to meet regulatory agencies requirements and expectations.

Please, take a look at our lastest CMC Case Study !

  • 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