For cell and gene therapies (CGTs) and other complex biologics, US and EU regulatory processes vary by more than just jurisdictional oversight. In this eBook we share the five key differences in the drug development and review process for companies hoping to gain market access through US Food and Drug Administration (FDA) or European Medicines Agency (EMA) approval—as well as tips for navigating these differences.
Explore the major differences in the drug development and review process for companies in the US vs. the EU.
Thermo Fisher Scientific is helping to revolutionize the world of cold chain logistics with our truly end-to-end supply chain solutions. From cold to cryo, we can handle a wide array of biomaterials, with services spanning transportation, warehousing, labeling, packaging, and distribution. Learn more about our industry-leading capabilities here.
Download our fact sheet to discover how we deliver life-changing treatments to patients in need.
Technology transfers can be tricky. A misstep or delay in one area can snowball into problems in other areas of the project. Likewise, inadequate planning or poor execution can introduce major risks and put the end goal of the project in jeopardy. The necessary foresight and a detailed project plan are essential elements to ensure the project runs smoothly, both on-time and on-budget, to achieve the ultimate end goal of regulatory approval. Check out our infographic to learn the 9 key tips for making your tech transfer easy and painless.
Discover our top tips for a smooth and successful tech transfer.
Bringing medicine to patients requires science, technology, and world-class expertise. It also requires a strategic partnership—bonded by key elements such as trust, communication, and collaboration.
At Thermo Fisher Scientific, we serve the pharmaceutical, biotech, and life sciences industries as a strategic contract development and manufacturing organization (CDMO) and clinical services partner. We believe that strategic partnerships fuel success, and we embed the elements of partnership into every operation, interaction, and step across your unique drug development journey. Through these elements, we can navigate everything from complex supply chain issues and compressed timelines to evolving regulations and a global pandemic. We know your challenges and have developed solutions you can trust to help bring your treatment to market faster.
We are your strategic partner for integrated drug development. We share your goals of improving patients’ lives and making the world a healthier place. Dedicated to excellence through effective partnership, we take pride in our collective ability to help you at every step of the development lifecycle, working as one team for a seamless experience.
Explore our end-to-end solutions and capabilities, access our extensive resource library, and learn the benefits of having a partner with global expertise.
Innovative solutions
Get new medicines to patients faster. Our CDMO and clinical trial services simplify and accelerate your journey to market.
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Our capabilities
Remove barriers in the drug development process- from early development through communication and everything in between.
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Insights and resources
Drug development is an ever changing industry. Stay connected to new discoveries, innovations, and expert scientific options.
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Global site locations
With more than 60 locations worldwide, we are committed to providing integrated, end-to-end solutions across all phases of development.
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Take advantage of our expertise in drug development with an unparalleled global network of sites; scientific, technical, and regulatory experts; a comprehensive range of tailored solutions; and flexible business models customized to meet your unique needs. Our integrated solutions include powerful digital platforms for timely visibility and collaboration, streamlined project management and partner communication, and our commitment to full project and process transparency at every step of your drug development journey.
Take advantage of our expertise in drug development with an unparalleled global network of sites; scientific, technical, and regulatory experts; a comprehensive range of tailored solutions; and flexible business models customized to meet your unique needs. Our integrated solutions include powerful digital platforms for timely visibility and collaboration, streamlined project management and partner communication, and our commitment to full project and process transparency at every step of your drug development journey.
Find your missing element with Thermo Fisher Scientific