We can provide consultants or contractors on a fee for service basis, with expertise in various quality, operational engineering and technical roles for the medicinal products; biotechnology and natural products; healthcare; consumer products and functional food sectors.
We understand the spectrum of risk/compliance across these sectors and understand how the needs and resources of a start-up business differ from those of an established organisation.
Whether you are just entering the regulated sector or are a well-established business, we can help find best practice solutions to meet all the quality, technical, engineering and compliance requirements.
We have the capability to deliver solutions suitable for multi-nationals, but don’t bring these to smaller businesses. We also use our experience from working with smaller organisations to find and improve inefficient practices in larger organisations.
New Wayz offers a comprehensive range of consulting and contract services including: (link to each page)
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Regulatory, compliance; validation and engineering support for medicinal products
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Risk management, product safety and compliance support for natural and consumer products, functional foods and ingredients
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Operational excellence and product realisation
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Project and engineering assistance
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Manufacturing and supply chain support
Our core competencies include:
Quality Management: Quality risk management, quality systems design, training, document development; validation and qualification; product review; change and and CAPA management.
Product/Process understanding: sterile and non-sterile processing, cleaning, process expertise, test method development, stability and process validation.
Engineering expertise: project management, clean facility and process engineering, procurement and qualification, cost-effective and quality focused procurement.
Manufacturing science: applied statistics and tools for vendor assurance, sampling and testing, product review, process validation and improving process understanding and performance.
Computerised systems and IT: selection, procurement operation and validation of computerised systems process monitoring and control and widely used applications within a regulated environment.