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)
Regulatory, compliance; validation and engineering support for medicinal products
Risk management, product safety and compliance support for natural and consumer products, functional foods and ingredients
Operational excellence and product realisation
Project and engineering assistance
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.