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.
These projects have complemented and extended our current offerings in the region and provided significant value for our clients. Several examples are below.
Management of the divestment of the Immunohaematology (IH) business to ParagonCare
The IH business was integrated within the Seqirus and CSL systems and the business of supplying blood transfusion diagnostics needed to be maintained while it transitioned to new ownership.
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Obtaining government funding to expand R&D and manufacturing facilities
An international company with options to invest in multiple countries was seeking government funding as an incentive to invest in Australia.
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Professional Development and Industry Training in PICs Compliance and GMPs
CBE consultants have been the trainers of choice for HKPMA for several years.
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Provide operational and quality support for new medical device
Expert contracted operations and quality support for a startup Class III device design and development for virtual company moving to Phase 1 studies.
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Divestment of Seqirus contract distribution operations in Australia to Toll
The Australian contract distribution business of Seqirus was sold to Toll Holdings (owned by Japan Post).
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Provide consulting and representative services to design, license and complete a sterile compounding facility using isolator technology
CBE provided expert consulting services regarding the facility design, validation, quality system and GMP licensing for the sterile compounding facility using isolator technology.
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SAP Implementation, integrating Australian facility with international manufacturing network
An ambitious project timeline to implement a new SAP ERP system in line with its international practices - switching from another ERP environment.
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Provide consulting and Microbiology support in remediation of US FDA Warning letter
CBE provided expert consulting services focusing on Microbiology system remediation and response to USFDA Warning Letter and commitments.
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