IVD Manufacturing Services & Support for Diagnostic Manufacturers

 IVD Manufacturing

Risk Mitigation

Risk mitigation is a core concern of IVD manufacturers, driven by commercial best practices and regulatory needs. A partnership with a knowledgeable and supportive supplier is a significant advantage in today’s marketplace. Partner with us to access a comprehensive spectrum of solutions, including: 

  • Supply chain transparency
  • Proactive forecasting and inventory management
  • Change control notifications
  • Quality and regulatory support
  • A clear and comprehensive Enhanced Quality Program, aligned with detailed defined support levels
  • Critical raw material selection advice
  • Diagnostic Elite product range
  • Contract manufacturing of finished IVDs and components

Contract Manufacturing – Finished Reagents & Kits

Accelerate your IVD’s commercialization and reduce your risk by accessing external expertise and benefit from an alternative to manufacturing expansion and capital expenditure.

IVD manufacturers partner with us to outsource the manufacture of their finished IVD kits and components.  We offer vertically integrated production based on our expertise as both a raw material and contract IVD manufacturer. This leverages our existing kit production expertise alongside 350 years experience of manufacturing biologics and chemicals, and providing custom formulations and packaging, supported by our global sourcing strengths.

Order & Inventory Management Support

IVD manufacturers need a skilled supplier support team to be able to ensure a compliant, effective and efficient IVD manufacturing process.  From order management, inventory control, forecasting and documentary support, our dedicated team is here to support your IVD manufacturing needs. Please contact your account manager or submit a request to learn more on how this team to can support your IVD commercialization and risk mitigation activities.

Quality Services & Support

Our Quality Services department prides itself on meeting our customers' informational inquiries with prompt and complete responses. Our dedicated technical staff draws from its multi-disciplinary experience in the sciences to provide customers with information, product recommendations and technical assistance. Please contact your account manager or submit a request to learn more.

Change Control Notification

An integral part of risk management in IVD manufacturing is avoiding, or limiting, changes that may impact final assay performance, disrupt production, result in regulatory non-compliance, or introduce additional forms of risk. Partner with us and participate in our Change Control Notification (CCN) Program for your critical raw materials. The opt-in CCN program provides customers with written notification of specified changes to their nominated list of critical products. The program offers transparency and clarity on the time line and notifiable events and is based on the assigned quality level of the product. Please contact your account manager or submit a request to learn more.