Genetic Sciences OEM and Commercial Supply

For assay developers racing to market, commercial use rights are an essential requirement on the road to commercialization. Our team is aligned to help you navigate potential speed bumps with our experience in leading technologies.

For decades, we have invested in infrastructure and scientific talent to provide high-quality, scalable manufacturing. With over 50 expertly staffed distribution and manufacturing sites in operation, we can help provide supply chain security through our expansive global footprint, site redundancy, scale-up experience, and the financial stability that comes with it.

Understanding your business, the marketplace, and the industry at large is what makes a collaboration valuable. Our Genetic Sciences OEM and Commercial Supply team is that collaborator. We speak your language and can help provide the big picture strategy your innovation deserves. With the breadth of experience combined with our global connections, Thermo Fisher Scientific can hit the ground running and scale to any size.

You have a unique vision. A solution you want to bring to market that could really make a name for your company. And that’s the key: a product with your name, IP, and strategy. We get it. That’s why we offer specialty products, custom kitting, and everything in between.

• Specialty products
• Custom reagents
• Specialty oligos

Collaborating with us means you have a dedicated business development manager as your project champion to connect you with the right resources in R&D, manufacturing, and more. Our team can help you through the process of bringing a product to market so you can maximize your efficiency and avoid costly missteps.

Our experience in quality assurance and control, with premiere analytical chemistry methods and instrumentation, allows us to assess material quality and avoid downstream complications. We minimize batch variability so raw materials and products are consistent across production runs.

A molecular assay increases its impact when it can be used off the shelf when and where a test is needed. The convenience and stability of ambient tests result directly from the benefit of reagents that are dried-down or lyophilized eliminating the need for more expensive cold storage.

When a global shortage slows down your workflow, or even stops it from moving forward, it's not just an inconvenience. It's a halt on the execution of innovative solutions, some of which could make a real difference in the world. So what can you do?

Whether you are working on expanding your portfolio or innovating new assays and kits, customized solutions can help you achieve the scale and speed you need on your path to commercialization.

The European Union’s new In Vitro Diagnostic Medical Device Regulation (IVDR) becomes law in 2021, replacing the previous regulatory regime, the In Vitro Diagnostic Medical Device Directive (IVDD). So, what's the difference between the two? Read more to find out.

The In Vitro Diagnostic Regulation (IVDR) transition will bring positive changes to European Union (EU) regulation of medical devices and molecular diagnostic tests. But it also presents potential obstacles. Fortunately, Thermo Fisher Scientific can help you conquer these roadblocks quickly. We’re with you through the rough terrain.