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Recipe for Success: Five Reasons to Outsource Your Next In Vitro Diagnostics (IVD) Project to US

Case Study

Every day companies are pressured to achieve more with less resources. As an IVD manufacturer, you may have capacity/resource constraints or skill set availability challenges. You then must decide whether to develop these capabilities in-house or outsource. Here are five reasons why outsourcing to a trusted contract manufacturing partner might be the ideal solution.

Access to Complementary Expertise

Organizations may benefit from contracting outside skill sets complementary to their expertise. Contract manufacturing partners can provide unique process capabilities, equipment, and QC procedures that smaller organizations may lack. We offers private label services around our full range of reagent manufacturing capabilities performed by highly ­trained professionals in ISO 13485, ISO 9001, FDA CFR 600, and FDA 21 CFR 820 compliant environments.

Freeing Staff to Focus on Strategic Business Initiatives

Outsourcing allows for more efficient business practices by enabling companies to redirect their resources towards more strategic priorities like regulatory filings and product innovation rather than routine production. Take advantage of our global manufacturing capabilities and warehouse network to get your finished product where it is needed.

Reduced Time to Market

The use of turnkey contract manufacturing services can mean quicker time to market. Contract manufacturing service providers produce validated manufacturing processes faster and ensure a rapid and regulatory-compliant journey to market. We offers a vast array of packaging and kitting formats and options tailored to your specifications. Upon completion, we assemble your kits and labels to your specifications and provide them ready-to-ship to your customers.

Alleviate Capacity Issues

Manufacturers with existing products on the market may find that outsourcing allows them to free up production capacity. We provides experienced contract manufacturing services capable of minimizing potential risks presented by transitions in manufacturing location. Our expertise in methods transfer, scale up, and validation ensures your procedures are integrated into our quality systems. We provide “single point of contact” and long-term project management to ensure your project is executed per specifications.

Cost Efficiencies

A traditional contract manufacturer purchases production raw materials from the Bill of Materials from various vendors. Our core business activity is the production of raw materials with contract manufacturing as a value-add service, differentiating us from traditional contract manufacturing providers. Partnering with a contract manufacturing provider who produces raw materials can have significant implications for the cost of your materials.

The Bottom Line

Whether you are producing bottles of reagents or complex multi-component kits, we are a trusted partner for clinical diagnostics companies wishing to outsource their manufacturing projects. We provide contract manufacturing services across the broad spectrum of client needs with proven processes and systems that ensure technical support and reliability at all stages of development. Request a consultation or visit our manufacturing facilities to learn more about our contract IVD manufacturing capabilities.