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 – API (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

Associated services

Drug Development Consulting & Strategy

Currently developing a new medicinal product ? BlueReg can provide an end-to-end project plan to guide you from the development of your medicinal product right through to authorization and beyond.  We can provide advice and recommendations to ensure the shortest time to market by minimising any possible barriers during the development process and beyond.

Associated services

Advanced Therapy Medicinal Product (ATMP)

Looking for an Advanced Therapy Medicinal Product (ATMP) classification? BlueReg can guide you to submit a classification application to Health Authorities to determine if your product meets the requirements to be defined as an ATMP.

Associated services

Early & Expanded Access Programs in France

Looking to reach market earlier ? You can rely on the experience and expertise of our consultants at BlueReg for providing advice and efficient implementation of your Early Access Programs projects in France

Associated services

Scientific Advice & Interaction with Health authorities

BlueReg has extensive experience in scientific advice with the European Medicines Agency (EMA) and many national competent authorities. BlueReg can assist with all competent authority meetings.

Associated services

Clinical Trial Applications (CTA)

Looking to outsource Clinical Trial Applications? BlueReg offers a variety of services that bring together our global clinical and regulatory expertise to simplify your journey to market. The clinical development process can be complex and can cost your organisation significant time and money.

Associated services

Orphan Drug Designations (ODDs)

Looking to apply for ODD designations ? BlueReg can determine if your product is eligible for orphan drug designation and provide the necessary support for your EMA/FDA application.

Associated services

Paediatric Investigation Plans (PIPs)

BlueReg can provide a complete PIP writing service as well as any PIP modifications through the lifecycle of the product within the EU or US.

Associated services

EMA/HTA Parallel scientific advice

Looking for support with your EMA / HTA bodies Parallel Consultation?  BlueReg can provide a team of highly experienced consultants specialised in regulatory affairs, market access and scientific writing.  Our consultants can advise you on all steps of the procedure and author the required documents required for this important process.

Case study

Marketing Authorisation Holder Transfer for 60 MAs

Our client a global pharmaceutical and biotechnology company specialising in the research, development and marketing of medicines and vaccines for...

Learn more


Line - Organism