Regions We Service
CBE works extensively across the Asia Pacific, providing hands on training, technical assistance and strategic services.
A selection of CBE projects undertaken are listed under each region.
Hong Kong
South Korea
Japan
China
Vietnam
Thailand
India
Bangladesh
Indonesia
Singapore
New Zealand
Melbourne
Adelaide
Sydney
Townsville
Perth
Hong Kong
- FDA and TGA Drug Inspections
- PICs Remediation
- Biologics Facility Design
- Strategic, technical and regulatory advice on cell therapy program
- Authorised Person training
- Computer Systems Validation
- Strategic, technical and regulatory advice on cell therapy program
South Korea
Japan
- FDA/PICS GMP Gap Analysis
China
- NMPA (China) GMP Compliance Reviews
- Mock FDA Inspection
- NMPA (China)) Inspector validation training
Vietnam
Thailand
- Pre TGA Gap Analysis
- Technology Transfer training
India
- PICs/TGA Remediation
- Validation training
Bangladesh
Indonesia
- Training course on Pharmacovigilance for Developing Countries Vaccine Manufacturing
- Process/Cleaning Validation review for TGA inspection preparation
- Cleaning Validation training
- Technology Transfer training
Singapore
- Facility and process design assistance for TGA readiness
- Computer Systems validation
- Process and Cleaning Validation training
- Technology transfer training
New Zealand
- Process and GMP consultant for design, build and operate lactose facility
- GMP and process engineering assistance for sterile IVD and biotechnology products for EU
- Consultant to a start-up cord-blood banking facility
- QA and Validation Manager for producing sterile injectable products
- Establish medical store and repacking facility for NZ Defence Force
Melbourne
- Strategic and technical advice to a Start Up Biotechs
- Advising on R&D organisation and strategy
- Ongoing strategic support and project management for major multinational manufacturer
- Class III Device Development Project
- Assisting design and licensing of biological and clinical trials facility
- GMP Compliance PQS Projects
Adelaide
- Design of microbiome facility
Sydney
- Compliance and improvement projects for facility expansion and ongoing operations
- GMP Compliance PQS Projects
- Strategic and technical advice
Townsville
- Project Management and Strategic advice James Cook University
Perth
- Sterile Compound GMP License
Our Clients
CBE has worked with leading organisations across the sector, including:
Our Projects
Leveraging our significant industry experience and world-wide network, the CBE partners and their affiliates have successfully completed a range of projects.
CBE have delivered over 450 projects, across Australia and into the Asian region, providing significant value for over 250 clients.
Multiple projects, including a selection of some of our larger, multi-year projects are:
- Management of a business divestment
- Critical review of R&D programs
- Compliance remediation (TGA, FDA) and capability build to support organisation transformation
- The design, validation, completion and licensure of sterile manufacturing facilities
- The development and establishment of Quality Systems for spinouts, startups and SMEs
- Due diligence prior to acquisition
- Obtaining government funding to expand R&D and manufacturing facilities in Australia or an international client
- Professional Development and Industry Training in PICs Compliance and GMPs
- Management of outsourcing of major distribution contract
- SAP Implementation, integrating Australian facility with international manufacturing network
- Technical advice to governments for major infrastructure investments
- Development of commercialisation strategy for new products
- Process development to aid scaling products to GMP manufacturing
