Our Regions

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

  • FDA Preparation Training

Japan

  • FDA/PICS GMP Gap Analysis

China

  • NMPA (China) GMP Compliance Reviews
  • Mock FDA Inspection
  • NMPA (China)) Inspector validation training

Vietnam

  • PICs (PQS) Workshops

Thailand

  • Pre TGA Gap Analysis
  • Technology Transfer training

India

  • PICs/TGA Remediation
  • Validation training

Bangladesh

  • Vaccine GMP Training

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