早期阶段的解决方案
临床前- I期
Early-phase pharmaceutical development programs often experience challenges unique from those of later phase and commercial programs. Navigating the complex 监管 landscape requires experience to effectively design, 在提交IND之前开发和收集高质量的数据, 比如材料表征, 溶解度, 产品稳定性和安全性. When you find the right development partner, you increase the likelihood of advancing your product.
网赌最正规的平台是来支持你早期项目的. 我们的发展专家运用他们的聪明才智, 技术技能, 经验丰富，能够找到适合您需求的创造性解决方案. 在每个阶段, 我们的专家与您紧密合作, while providing effective project management open communication and transparency.
Our state-of-the-art facilities support the following services for early-phase programs:
过程开发
We take a proactive approach to early-phase pharmaceutical process development and apply our 专业知识 and creative problem-solving skills to optimize your chemical process.
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制定发展
Our dynamic formulation development services will adapt to your early-phase challenges as the needs arise. Our scientists have the experience and knowledge to help you advance.
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固态表征
Our veteran team of solid-state chemistry experts will work with you to address your unique early-phase development challenges and help you achieve your specific goals.
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分析测试
通过提供全面的分析测试服务, 我们可以支持发展, 对程序进行验证和测试, 无论是早期阶段, 后期或商业, and ensure your materials meet the highest standards for safety and quality.
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微生物学
We offer extensive microbiology services at our FDA-registered facilities, which are fully compliant with all GMP and GLP testing services and standards.
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稳定的存储 & 测试
We offer complete stability storage and testing services at all phases of development, 包括商业项目.
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原料药生产
We provide lab-scale and kilo-scale manufacturing for pilot API scale-up for pre-clinical material and for phase I clinical trial material, including all the analytical support required to reach early-phase 监管 milestones.
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药品制造业
Our robust manufacturing and packaging services provide solutions to support the changing demands of your early-phase clinical program.
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