The right partner makes all the difference

 

Bringing a diagnostic or life science product to market is a difficult task requiring continuous innovation and quality materials to support your vital efforts. Our end-to-end portfolio of customizable products, secure global supply, and know-how, through decades of tested experience is the support you can rely on to accelerate your work and bring your ideas to market faster.

 Brochure: Molecular biology solutions and custom capabilities for commercial supply
 



Sourcing success and solving challenges with the full weight of
Thermo Fisher Scientific behind you

 

When you have a solid partnership as the foundation for your commercialization strategy, you find that you make it to market faster, wiser, and without the address stress and compounding cost that comes from trying to do it all on your own.
 

Quality

Ensuring you have complete control over the quality of your raw materials

We have learned for quality control to be the most effective, it should not be treated as a discrete step of manufacturing. Through our personalized approach, advanced quality systems management, and global reach protected by best-in-class cold chain capabilities we have reduced batch variability with innovative quality assurance and quality control testing.

Accreditation and compliance*

  1. ISO 9001, ISO 13485, and ISO 14001 certified quality systems
  2. US 21 CFR Part 820 Quality System (current good manufacturing practice, cGMP)
  3. Class I, II, and III medical devices and general-purpose reagent certified manufacturer under USDA guidelines
  4. US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA) registered media production sites
  5. Select Good Laboratory Practice (GLP) accredited sites
  6. Readily available and downloadable Certificates of Analysis (CoA) and Certificates of Conformance (CoC)

*Note: Certain regulatory standards are available at specific sites only

Customized solutions

For your one-of-a-kind products and unique commercial needs

Execute your unique vision through a wide menu of custom manufacturing options and services. These include simple component alterations, modified reagents, molecular synthesis, novel consumables, custom packaging, and everything in between.

Our manufacturing scientists are ready to discuss your individual project and the needs required to turn your concept into a packaged product. If our extensive suite of manufacturing solutions does not address your specific project needs, we can always find a custom solution that can.

Case study: Improve performance through custom plastics

Discover how our flexible approach to commercialization can help you maximize the potential of our industry-leading products.

 View case study
 

OEM global manufacturing map

Supply chain

Far-reaching infrastructure delivers a secure supply chain

For decades, we have strategically invested in building and acquiring new manufacturing sites, distribution centers, production equipment, and scientific talent with the aim of ensuring our ability to provide high-quality raw materials and commercial services wherever and whenever needed.

With an ever-growing list of more than 50 expertly staffed distribution and manufacturing sites in operation, we can offer you an unprecedented level of supply chain security through our far-reaching global footprint and site redundancy, scale-up experience, and financial stability that comes with it.

Diversity of experience

Minimizing risk through diversity of experience

Our manufacturing experience has supported a growing number of products across a diverse group of therapeutic and diagnostic focus areas including oncology, infectious disease, cell therapy, agricultural and environmental applications, and food safety.

Bringing a product to market also requires know-how to navigate regulatory, legal, and financial elements. When partnering with our OEM supply and commercialization teams, we bring leading regulatory affairs, legal, and financial experts to support submission, approval, and market launch.
 


Source success and solve challenges with the full weight of
Thermo Fisher Scientific behind you.

Contact us


FAQ’s

 

Our team has established an impressive resume of scale-up processes due to the substantial production cycles they have already successfully completed for several products. This experience gives them a better bird’s-eye view of the path to production at larger scales without sacrificing quality. With better expectations and planning, our scale-up manufacturing efforts are often incredibly efficient compared to other organizations. Leveraging our experience in scaling up our own products, and those of partners, we can apply our well-earned knowledge to minimize the risk for your product.
 

While manufacturing experience is a clear focus for our work and teams, it is not the only type of experience we bring to our partnerships. Bringing a product to market requires much more than just making or assembling the product—it also requires know-how to navigate regulatory, legal, and financial elements. When partnering with our OEM supply and commercialization teams, we also bring leading regulatory affairs, legal, and financial experts to support submission, approval, and market launch. Importantly, your devoted Commercial Supply Business Development Manager (BDM) will serve as your internal project champion to fully connect our entire team and yours.
 

Your devoted Commercial Supply Business Development Manager (BDM) will serve as your internal project champion offering support and training through every step of your processes. With countless combined years of experience.
 

For life science product developers, the trouble starts when a key supplier runs into issues beyond their control, like starting material shortages, increased reagent demand, regulation changes, civil unrest, economic downturn, natural disasters, and disease outbreaks. In truth, it is remarkably difficult to fully insulate your product development from supply chain challenges without profound standing infrastructure that can be mobilized at a moment's notice. This is where Thermo Fisher Scientific stands alone in our ability to support our partners.
 


Dedicated OEM teams for your focus areas

 

For Research Use Only. Not for use in diagnostic procedures.

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