OEM Solutions: Custom Commercial Solutions

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

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 comprehensive standing infrastructure that can be quickly mobilized. This is where Thermo Fisher Scientific stands alone in our ability to support our partners.