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What we offer
New Wayz Consulting Ltd delivers consulting services based on a risk-based
approach for businesses entering or established in the Good Manufacturing Practice
(GMP) regulated environment.
We have the expertise and commitment to provide best practice solutions to
meet all operational and
project related quality, technical, engineering, and
compliance demands.
We offer a comprehensive range of consulting services in the following areas:
These services are used by our clients in pharmaceutical, medical device, complementary medicines, cosmetic, verterinary, biotechnology, and related industries.
Who we are
New Wayz is a New Zealand owned company. Our team of consultants has extensive and current technical expertise gained both in New Zealand and internationally. This experience enables us to take a pragmatic approach to regulatory requirements delivering solutions that are appropriate and effective for our wide range of client needs.
Our business objective is to consistenly provide customised, practical and compliant advice, and deliverables of the highest technical standard. For our clients we aim to effectively transfer knowledge, expertise and experience to enable them to compete successfully.
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| © New Wayz Consulting 2006 - 2009 |
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- Qualification & Validation
- Validation planning and management
- Process optimisation, performance qualification and process validation
- Process automation
- Risk and Impact assessment
- Aseptic processing and sterilisation
- Computer systems
- Electronic records
- Cleaning validation
- Analytical/Microbiological methods and equipment.
- GMP / GLP and Regulatory Compliance
- Quality systems development and implementation
- Gap analysis and Quality Improvement Planning
- Incident investigation, corrective and preventative action
- Supplier and contract manufacture assessment
- Medsafe, TGA, FDA/Q7A, European and other international codes
- Regulatory Audit preparation
- Review of regulatory compliance.
- Good Engineering Practice (GEP)
- Management of integration of GMP requirements into construction and procurement projects
- Quality systems management for capital projects and contractors
- Feasibility studies, conceptual building and utilities design, project scope planning
- Management of process automation contractors.
- Manufacturing Best Practice and Technical Support
- Quantitative analysis and statistical process control
- Continuous Improvement
- Technical training and staff development
- Process re-engineering for profitability improvement, reduced wastage or product improvement
- Calibration services.
- Crtical Process & Equipment Engineering
- Aseptic manufacture and sterilisation
- Quality water, pure steam and product contact utilities
- Steam/Clean/Wash systems
- Processing equipment procurement
- Specification, selection, installation and commissioning of turn-key process solutions
- Process re-engineering for profitability improvement, reduced wastage or product improvement
- Microprocessor, PLC and process automation design and commissioning
- Planned maintenance and calibration management programs.
- Contract & Business Services
- Quality Assurance Management
- Quality Systems design
- Project Support
- Project Management
- Training and Training Solutions
- Feasibility studies, conceptual design, project scope planning
- Business continuity planning, waste and environmental management.
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