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Cell and Gene Therapy Services and Products
Uncertain of the steps to reach the end goal for your cell and gene therapy? Accelerate your program with expert guidance and an innovative portfolio of cell and gene therapy services and products.
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Artificial intelligence and machine learning are enhancing workflow efficiency and fostering collaboration among pathologists around the globe. Learn how digital pathology speeds up image analysis, drives decision making, and supports primary and peer review.
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Frequently Asked Questions (FAQs)
Will you be available when I need you?
Simply, yes. Dedicated study directors and program managers, and extensive client support services work together to put your mind at ease.
We know that questions arise and needs change. Whether you want to check in on progress or need a new start date, we strive to make it easy to work with us. We’ve purposely built a global network of facilities through the acquisition of best-in-class companies that enhance our ability to serve you. Harmonized practices at our sites around the world afford greater flexibility and speed in the contract and delivery of services when and where you need them.
Will I feel like a priority?
Simply, yes. Every client and project is unique and deserves the same dedicated attention.
Around the globe, our 14,400 employees all share the same goal: to improve the quality of life for patients around the world. This common mission shapes our perspective to see every client as a true partner in research and development. Whether you are in an academic research facility, a virtual startup, a mid-size biotech, or a division of big pharma, your project is equally important to our team. It doesn't matter if you’re placing standalone studies or engaging in a multifaceted collaboration with us, you can expect tailored solutions and personalized attention to your needs. Our team provides flexible, responsive, and personalized support and each project is managed with the same dedication and attention as if it were our own.
Can you help me sort out complex regulatory requirements?
Simply, yes. With a team of Regulatory and Scientific Advisors we can help manage strategic, operational, and regulatory risk across multiple dynamic markets.
Navigating intricate regulatory requirements is one of the most challenging aspects of pharmaceutical, agrochemical, and industrial chemical product development. Our advisors are dedicated to protecting you from regulatory risk while anticipating and preparing for future challenges. Many are committee members for regulatory initiatives like ICH guidelines, REACH, and SEND and actively participate in local and global professional societies. Applying a collaborative approach and deep understanding of your product, they will shape the best regulatory and scientific strategy to advance your program across the life cycle of product planning, development, and regulatory submission.
Among our experts are former industry regulatory, scientific, and executive professionals who will assist in regulatory planning and applications to agencies around the globe for any type of product from small molecules to larger proteins, cell and gene therapies as well as viruses, nanoparticles, veterinary medicines, agrochemicals, food additives, and medical devices.
Within Charles River we ensure your program is kept on the right track by utilizing a risk-based auditing approach, conducting approximately 20,000+ audits per quarter for safety assessment studies alone. Governed by written policies that guide compliance, our robust data integrity program is built to minimize your regulatory risk and accelerate time to market.
Can you drive an entire program?
Simply, yes. It’s our specialty.
Charles River is willing and able to take on stand-alone studies or transactional accounts, but our real value lies in our unique ability to shepherd clients from bench to bedside, offering a portfolio of services that span the drug development continuum from basic research through the support of manufactured products. Seasoned advisors and scientists who’ve been in your shoes are with you every step of the way, helping you to see around the corner for more efficient, successful programs.
With access to one of the industry’s most comprehensive portfolios – from early discovery to market support – we are uniquely qualified to map and drive your journey though product development. When you partner with Charles River you gain the confidence of working with a company who has supported the development of 85% of the drugs approved by the FDA, additional therapies with other global regulatory agencies, and products in the chemical and agrochemical space around the globe in the last year alone.
Will you let me know if something goes wrong?
Simply, yes. As your partner in development, we strive to earn and keep you trust by maintaining total transparency.
Drug development doesn’t always go according to plan. When the unthinkable happens, trust Charles River to keep you in the loop. In business, there are no rules that govern communication, but we know your trust – and our credibility – depend on communication, especially when things go wrong. We are a true extension of your team; as your partner, we promise to keep you apprised of progress, challenges, and our strategy to move forward.
Will your organization continue to grow?
Simply, yes. Growth fuels innovation and makes it possible to serve. For more than 70 years, we have seen technologies advance and new diseases emerge. Our one-man laboratory has evolved into a worldwide support network, allowing us to act as a steadfast partner to our clients, from discovery to lot release testing. By carefully cultivating our portfolio, establishing technical partnerships, and strategic alliances, our growth has become a continuous tactical effort in anticipating your drug development needs.
In the last decade, our organization has more than doubled its workforce and global footprint, and we will continue to do so. Why? It is our mission to acquire the scientific excellence and technologies that allow us to fill gaps in our portfolio and best meet your needs. Through our growth and collaborations, we strive to continue as the company you want to work with, delivering tailored service, personal attention, and shared values.