Product Development & CMC Services

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Product Development & CMC Services

产品开发和 CMC 服务

CMC 服务

我们的药学研究服务内容广泛，包括从临床前阶段到临床II期试验的药物产品开发、分析和临床试验样品生产供应。我们拥有最先进的分析仪器，可提供全面的分析检测服务，包括原料药/制剂的放行、稳定性和溶解性等分析检测服务。

合规历史

方达医药的药学团队具有卓越合规历史，严格遵循ICH、FDA GMP的指导方针进行运营。我们的设施、项目流程和质量体系可在任何时间接受申办方和监管机构的例行核查。

实例： 我们拥有无与伦比的合规性和质量记录。

制剂开发人员在开发稳定有效的口服、无菌和局部剂型时具有完整的经验，我们的 CTM 服务还提供这些剂型产品的早期临床生产。

我们的价值

整合：产品开发的一站式服务
以客户为中心：灵活运营以满足客户要求
快速响应：与客户保持沟通并及时更新项目状态
强大的问题解决能力：帮助客户克服具有挑战性的技术难题
良好的质量和合规记录

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