創新的eCTD,RIMS,藥物警戒和IDMP軟件解決方案和服務

EXTEDO是唯一提供涵蓋整個監管環境的軟件解決方案和服務的供應商。 EXTEDOsuite將創新與合規性,質量與可用性相結合。

 

全球社區的監管軟件解決方案

EXTEDO使60多個國家/地區的35個監管機構和850名客戶能夠提供輕鬆的合規性。

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監管信息管理和eCTD軟件解決方案和生命科學服務

EXTEDOsuite帮助维护制药行业和监管机构之间的关键关系,确保您在生命科学领域的业务运行符合有效的产品注册和维护流程。

产品注册/IDMP软件

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申请提交管理软件

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药物警戒及药物安全软件

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计划及追踪软件

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“在我们使用DOCmanager之后,由于它巧妙地子母概念,我们在国际提交记录上的花费从6个月骤降至1到2个月。“

监管信息和管理部门主管, Merck Serono,

“eCTDmanager 难以置信的用户友好界面和直观的页面设计使得我们在使用时不再需要IT部门的支持。EXTEDO团队在我们的合作中给我们提供了巨大的技术支持,他们的工作高效且专业!“

法规事务总监, Guangzhou Henovcom Bioscience Co. Ltd

“EXTEDO是真正理解市场需求的公司的典范!“

业务发展,技术运营和国际业务总监, Genericon

由于EXTEDO软件解决方案的用户友好性,培训过程非常顺利,我们在安装成功后几乎立即就可以使用提交申请了。“

质量保障和法规事务经理, PHF SA

监管信息管理—EXTEDOsuite

EXTEDO专注于优化客户的电子管理商业流程,EXTEDOsuite是目前独有的完整覆盖整个监管环节的软件。

大型企业解决方案

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中小型企业解决方案

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监管机构解决方案

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Latest Blog Posts

5 Ways Cloud-based Computing is Changing Business

The cloud revolution is here, and businesses around the world are enjoying the many benefits that cloud-based computing offers.

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EU Medical Device Regulation 2020 - What You Need to Know

On 26 May 2020, the new EU Medical Device Regulation and the EU In-vitro Diagnostics Devices Regulation will come into effect. This blog post will...

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Pharmacovigilance in a No-Deal Brexit Scenario

In this blog post we highlight the most important changes to be wary of in the case of a no-deal Brexit, according to the UK government.

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Latest Events

DIA Middle East Regulatory Conference (MERC)

The 13th DIA Middle East Regulatory Conference (MERC), shaped in partnership with the EFPIA Middle East Regulatory Network (MERN), is built on the...

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Complimentary Webinar: Effortless Collaboration -  Reduce the Complexity of Viewing and Reviewing with eSUBmanager

EXTEDO invites you to its complimentary webinar "Effortless Collaboration - Reduce the Complexity of Viewing and Reviewing with eSUBmanager".

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5th Pharmacovigilance & Drug Safety Summit

With the goal of making medicine safe for people all over the world, there are few issues more important than drug safety. And while predicting the...

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EXTEDO eCTD Workshop in Greece

Register now for our eCTD workshop in Athens, Greece!

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