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Celegence is an outstanding company with excellent services. Their dedication to their clients is exceptional, and their team always goes above and beyond to ensure customer satisfaction. I have been working with them for over a year now, and I couldn't be happier. The level of professionalism and expertise they bring to the table is unmatched. I highly recommend Celegence for all your business needs.
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Celegence:生命科学监管解决方案的一站式商店
Celegence 是生命科学监管解决方案和服务的领先供应商。该公司专注于医学写作、医疗器械法规、标签、IDMP 等。 Celegence 拥有一支技术精湛的专业团队,他们都是各自领域的专家,致力于提供满足客户独特需求的高质量解决方案。
在 Celegence,我们了解生命科学公司在法规遵从方面面临的挑战。该行业在不断发展,新的法规和指南不断出台。这可能使公司难以跟上最新要求并确保它们完全合规。
这就是 Celegence 的用武之地。我们提供一系列服务,旨在帮助我们的客户驾驭生命科学监管的复杂世界。无论您需要医疗写作、器械法规、标签或 IDMP 合规方面的帮助,我们都能满足您的要求。
我们的团队由经验丰富的专业人士组成,他们在生命科学监管的各个领域工作多年。他们为所从事的每个项目带来丰富的知识和专业知识——确保我们的客户获得最好的服务。
医学写作服务
Celegence 擅长的领域之一是医学写作。我们的团队在创建高质量文档方面拥有丰富的经验,例如临床研究报告 (CSR)、临床试验方案 (CTP)、研究者手册 (IB)、患者信息传单 (PIL) 等。
我们理解这些文件的准确性和良好的书写是多么重要——毕竟,它们构成了任何监管提交的重要组成部分。这就是为什么我们在创建它们时非常小心 - 确保它们符合所有相关准则,同时又清晰简洁。
医疗器械法规
Celegence 可以提供帮助的另一个领域是医疗器械法规。我们了解该领域的复杂性——尤其是考虑到欧盟医疗器械法规 (MDR) 和体外诊断法规 (IVDR) 最近发生的变化。
我们的团队对这些法规有着深刻的理解,可以帮助您轻松驾驭它们。我们可以协助处理从设备分类到合格评定、技术文档等一切事宜。
标签服务
在 Celegence,我们还提供标签服务。我们了解您的产品标签准确合规的重要性 – 毕竟,这是客户在购买您的产品时首先看到的。
我们的团队可以帮助您创建符合所有相关准则的高质量标签,同时清晰易懂。我们可以协助处理从标签设计到翻译的一切事务——确保您的产品立即上市。
IDMP 合规性
最后,Celegence 提供 IDMP 合规服务。 IDMP 代表医药产品标识——由国际标准化组织 (ISO) 制定的一套标准,旨在通过提供一种标准化的标识方式来提高医药产品的安全性。
我们了解生命科学公司遵守这些标准的重要性——尤其是考虑到欧洲药品管理局 (EMA) 等监管机构最近引入的变化。我们的团队可以帮助您确保您的数据完全符合 IDMP 要求——让您高枕无忧,因为您知道您的产品是安全有效的。
结论
总之,Celegence 是生命科学监管解决方案和服务的领先供应商。凭借我们在医学写作、医疗器械法规、标签、IDMP 合规性等方面的专业知识,我们致力于帮助我们的客户轻松应对生命科学监管的复杂世界。
如果您正在寻找一个可靠的合作伙伴来帮助您实现合规性,同时提供专门针对您的需求量身定制的高质量解决方案——没有比 Celegence 更合适的选择了!