Services

Customers are supported throughout the IVDR registration process by providing the technical documentation and product-specific regulatory information required to support registration activities. Drawing on experience maintaining IVDR-compliant products since 2022, our regulatory team works closely with customers to help facilitate the registration process

A Certificate of Analysis (CoA) is provided with every product, confirming that each production lot has been tested against defined quality specifications and meets established acceptance criteria. This ensures full traceability and gives customers confidence in the quality, consistency, and performance of each product supplied.

Dedicated regulatory support is available throughout the registration process, including responding to regulatory queries, supplying requested documentation, assisting with information needed to support timely submissions and approvals, and accommodating audits by customers and their Notified Bodies through the provision of relevant documentation and technical support where required. Our team works collaboratively with customers to help address requirements efficiently and support efficient regulatory submissions and timely responses to authority or customer requests. Customers have direct access to NewBio’s regulatory and technical teams throughout the registration process, ensuring timely responses to documentation requests and regulatory queries.

A formal complaint handling process is maintained within our ISO:13485 accredited Quality Management System. Customer concerns are documented, reviewed, investigated where appropriate, and used to support continual improvement and post-market surveillance activities.

Customer feedback is routinely collected and reviewed to monitor product performance and customer experience. Feedback and quality data are analysed for trends, enabling the early identification of recurring issues, opportunities for improvement, and proactive quality actions where required.

Continuous improvement is embedded within NewBio’s QMS. Through the review of customer feedback, quality metrics, investigations, audits, and performance data, opportunities for improvement are identified and implemented to enhance product quality, customer satisfaction and operational effectiveness.

NewBio supports its distributor network by enhancing partner visibility through its website, helping customers identify local distributors and access relevant contact information. This increased exposure helps strengthen distributor presence and facilitates connections with potential customers.

Training materials and supporting documentation are available to help distributors develop product knowledge, support customer enquiries, and facilitate effective product implementation.

The NewBio logistics team provides the documentation required to support international shipments, helping ensure products are supplied efficiently and in compliance with applicable import and export requirements. This includes commercial invoices, Certificates of Analysis, declarations, and other shipment-specific documentation as required

NewBio coordinates courier and freight arrangements to support the timely and reliable delivery of products worldwide. Our team works with trusted logistics partners to manage shipments, provide relevant shipping documentation, and help ensure products reach customers efficiently.

NewBio provides clear guidance on product handling, storage, and transportation requirements to help maintain product integrity throughout the supply chain. Our team is available to advise customers on best practices and specific handling considerations to support optimal product performance.

Flexible OEM supply solutions are available to meet individual customer requirements, including customised packaging, filled and labelled vials, private-label products, and specialist OEM solutions tailored to specific customer needs. Our scalable manufacturing capabilities support a range of customer requirements while maintaining consistent quality, reliable product availability, and compliance with applicable regulatory requirements, including those associated with OEM partnerships and customer-specific market registrations.

NewBio offers flexible purchasing arrangements to accommodate varying customer requirements, from small-volume orders to large-scale supply agreements. Our adaptable approach helps customers manage demand, optimise inventory, and maintain continuity of supply as their needs evolve.

NewBio offers long-term supply agreements to provide customers with security of supply, predictable planning, and business continuity. Agreements can be tailored to forecasted demand and may include fixed pricing arrangements, helping customers plan budgets, manage inventory, and support long-term growth with confidence.

NewBio offers bulk reagent supply to support customers with in-house manufacturing, packaging, or further processing requirements. Products can be supplied in volumes tailored to customer demand, providing a flexible and reliable solution backed by consistent quality and supply continuity. Bulk reagents are manufactured under the same controlled quality processes applied to finished products.