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Biopharm CMC Manufacturing Solutions
There are many analytical challenges throughout the product lifecycle. Through our specialized Chemistry, Manufacturing and Controls (CMC) expertise, we deliver the highest quality data that you need to overcome them.
Unique Challenges. Customized Solutions.
More than 20 years of delivering biologic and small molecule solutions
GMP Testing Labs located in North America and Europe
Dedicated global biopharm CMC project management
到达下一个发展里程碑。
Every day is critical to reaching the next objective, whether it’s the CMC package supporting IND, NDA/BLA submission or meeting acceptance criteria for release of drug product. We not only help you reach those objectives more efficiently, we help you to understand the implications of short-term decisions on long-term goals.
Managing the product lifecycle.
Whether you employ a minimalist or an enhanced Quality by Design (QbD) approach, demonstrating control of the product and the process throughout the lifecycle is paramount. Covance helps you to make the best choices of how you manage and what you spend to establish and maintain control.
Navigating the complexity of CMC manufacturing.
CMC和支持它的分析封装可以具有数百种不同的元素，需要良好协调的功能和在全球质量系统框架内运行的专业专业知识。我们提供最坚固但具有成本效益的解决方案，以满足适当的质量和监管标准。
Biologics
Reaching development milestones faster and effectively managing your program from discovery to post-launch requires specialized expertise and end-to-end solutions. Here are some of the areas where we can help you:
Small Molecule
在临床yaboapp体育官网前和早期的临床开发中，您可以从愿望中受益于团队的一部分。我们可以共同创建量身定制的解决方案 - 包括API开发，预兆，配方，监管，分析，技术转让和IND / CTA启用CMC封装。