OUR SERVICES

Technical and Scientific Due Diligence

CBE consultants have extensive experience in technical and business operations, making them ideally placed to assess companies for acquisition/ investment or preparing companies for divestment by providing reviews and recommendations in the following areas:

  • Product development pipeline
  • Existing infrastructure (site, labs, production facilities, staffing)
  • Manufacturing systems and processes
  • Quality systems
  • Products
  • Product costs and costing systems

Client Services and Representation

Our consultants have deep understanding of value from the client side, having held senior industry positions, responsible for procuring and managing third party resource or capital projects.  CBE offers support to clients  to ensure they get value from procurement projects and engagements with third parties in the following areas:

  • Act as a client representative or advisor for development of technical projects
  • Develop procurement strategy, contracts or policies and procedures
  • Represent the client in third party discussions and negotiations
  • Manage or facilitate control of specialist consultants and contractors
  • Develop and build client capability to be self-sufficient in these areas.

Technology Transfer and Plant Expansion

CBE supports companies in technology transfer and plant expansion in the following areas:

  • Facility and process planning and conceptual design
  • Project scope, feasibility and financial justifications
  • Critical review of engineering capabilities and gap analyses
  • Sourcing and procurement assistance
  • Project delivery and quality planning to meet timelines
  • Process development and Quality by Design (QbD)
  • Process validation

Technical Consulting and Strategy

CBE draws on substantial experience to expedite solutions in the following areas:

  • Regulatory and Manufacturing strategy and planning
  • Quality compliance management and improvement
  • Improve efficiency and effectiveness of Quality Systems.
  • Operational and Quality Risk Management
  • Technical and engineering review and improvements
  • Operational excellence and change management
  • Partnering, out-sourcing

Knowledge Management and Capability Development

The team at CBE have seen many operations in action across the industry and can assist companies in getting systems in place so the right people have the right data to make the best decisions. This is a critical area in Quality Risk Management. We assist in the following areas:

  • Resourcing reviews and strategy
  • Business process reviews
  • Capability analysis and planning
  • Technical training and education
  • Organisational design

OUR FOCUS

Facilities and Process Design

The CBE team have all had front line experience in the development, design, and delivery of GMP compliant facilities, equipment and process systems. We have also been responsible for running and maintaining such facilities. Rather than offering a generic design house, CBE provides client-side services for conceptual planning, review, procurement and oversight that maintains a cost effective focus on compliance. In particular:

  • Strategic project planning and engineering solutions
  • Facility concept layout and process flow planning
  • Project management and procurement strategy
  • Project quality planning and management
  • Cleanroom design testing and validation
  • Biocontaminant facility design
  • Equipment and process selection and procurement
  • Compounding pharmacy, cell culture and PET facility design
  • Commissioning and qualification strategy and guidance

GMP / Quality and Compliance

CBE has a vast depth of knowledge and experience in quality and compliance, built up over decades of working in the exacting and highly regulated Biopharmaceutical industry. We understand that quality, GxP and compliance is business critical and that it is challenging to get the right balance between over and under control. We provide pragmatic and experienced solutions that leverage clients quality systems and compliance initiatives.

We specialise in the following areas of quality and compliance:

  • GxP audits, gap analysis and remediation programs to PIC/s, FDA, EMA, TGA.
  • Data Integrity and Quality Metrics
  • Pre and post regulatory inspection support
  • Quality system development and implementation
  • Simplification of quality and compliance systems
  • Strategies for GMP education and staff competency
  • Quality Risk Management programs
  • Process validation, utilising Quality by Design (QbD) principles 
  • Strategic assessment of eQMS technologies

Research and Development

At CBE we understand how important it is to get the R&D strategy right so that it aligns with business needs. Our consultants have experience in leading teams of specialists in the following main areas:

  • New product registration
  • Product upgrades
  • Clinical trial applications and support
  • Production and commercialisation strategies
  • Product portfolio evaluations
  • Due diligence reviews

Operations Management

CBE’s consultants have extensive experience in managing teams within Pharmaceutical or Biopharmaceutical operations in all of the key areas of manufacturing operations and offer services such as:

  • Review of aseptic / sterile processing systems
  • Advise and optimise packaging processes
  • Review/implementation of contamination control and environmental monitoring systems
  • Conduct quality risk management reviews
  • Provide GxP training and personnel competency strategies
  • Develop risk based validation strategies
  • Advise on operational efficiency and compliance
  • Benchmarking operational functions to best practice
  • Advise on organisational design structure for business effectiveness within a GMP workplace
  • Evaluation of common IT solutions

Clinical Research and Regulatory Affairs

CBE provides high quality Regulatory Affairs and Clinical Research advice. To support this we have a strategic alliance with a number of experts in Good Clinical and Good Pharmacovigilance Practice. We also have an important strategic alliance with Plunkett Consulting http://plunkettconsulting.com.au. a firm with extensive experience in supporting companies in these areas.

OUR EXPERTISE

Biologicals

Pharmaceuticals

Blood Products

Natural Products / Traditional Medicine

Vaccines

Diagnostics

Medical Devices