CBE
BioTech/Drugs - Melbourne, VIC, AU
CBE Details
CBE represents Australia's leading consultants across the biopharmaceutical sector, providing strategic solutions and increased efficiency. We provide specialist, synergistic consultancy services with deep expertise in the key areas of Quality, Engineering, Manufacturing Operations, Supply Chain, R&D, Scientific and Technical Due Diligence, Compliance and Training. We provide specialist consulting services in all aspects of the product life-cycle across Australia and the Asia Pacific Region.CBE's Directors have extensive senior management and technical experience with leading global Biopharmaceutical and Pharmaceutical companies. We work directly with customers and include leading compliance, quality systems, operations, project management, engineering and process validation experts. CBE provides expertise in biologics, blood products, vaccines, APIs, drugs, sterile products, diagnostics and medical devices.Our core skills are focused in the following areas:• Compliance and quality systems gap analysis to FDA, EMA, PICs, TGA and other international standards• Facility and cleanroom design, engineering solutions, commissioning and qualification/validation oversight • Manufacture of sterile and non-sterile medicinal and biological products• R&D and operational strategies for the registration of biologics, medicines, blood products and new entities• Operational excellence and process improvement• Organisational improvement strategiesWithin these areas the services we offer include:• Consulting, planning and project management• Technical and scientific due diligence• Client services and representation• Technology transfer, plant expansion and scale-up• Knowledge management and capability development
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