CMC Product Development

BlueReg can support with the Chemistry Manufacturing and Controls (CMC) development of a successful product whilst ensuring quality compliance. BlueReg services in this area include strategic consultancy during global pharmaceutical development and lifecycle management. 

 

BlueReg has a dedicated team of CMC consultants with significant expertise in all areas of CMC development.  We have have expertise in all types of Active Pharmaceutical Ingredients (chemical, biological and herbals), drug product development, project management and decision making to drive investments. 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.

Our consulting services include the following:

  • Strategic consultancy during global pharmaceutical development and lifecycle management
  • Expertise in all types of Active Pharmaceutical Ingredient (API) (chemical, biological and herbals)
    • Development of Active Substance Master File (ASMF), Drug Master File (DMF) and Certificate of Suitability (CEP)
    • Development of USP / EP monographs
  • Drug product development:
    • Formulation (development and patentability), process (scale-up, validation and manufacturing strategy and Quality by Design (QbD))
    • Analytical development (development, validation and method transfer, gap analysis and specifications setting)
    • Stability studies (design, trend analysis and setting of shelf life)
    • Identification of contract manufacturing organizations (CMOs) and contract research organizations (CROs) and technology transfer

 

 

  • Project management: coordination of all activities in pharmaceutical development from API selection, product development, clinical supplies and transfer to CMO; registration and geographical roll out, including CMOs and CROs management
  • Decision making to drive investments: due diligence, gap analysis and expert reviews

Our experts

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