EXTEDO Opens New Office in Shanghai, China

With the planned introduction of eCTD in China in 2018 we see a significant opportunity to support the region through the EXTEDOsuite and our 20 years of industry knowledge. 

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Innovative eCTD, RIMS, PV and IDMP Software Solutions and Services

EXTEDO is the only vendor that provides software solutions and services covering the entire regulatory landscape. The EXTEDOsuite combines innovation with compliance, and quality with usability. 

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Regulatory Software Solutions for a Global Community

EXTEDO enables more than 35 regulatory authorities and over 700 maintained customers across 60 countries to deliver Effortless Compliance. Our clients range from small CROs to large multi-national pharmaceutical organizations. 

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Regulatory Information Management & eCTD Software Solutions and Services for Life Sciences

The EXTEDOsuite supports the critical relationship between the pharmaceutical industry and regulatory authorities, ensuring that your life sciences business operates a compliant and efficient product registration and maintenance process.

PRODUCT REGISTRATION & IDMP SOFTWARE


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SUBMISSION MANAGEMENT & eCTD SOFTWARE


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PHARMACOVIGILANCE AND DRUG SAFETY SOFTWARE


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REGULATORY PLANNING AND TRACKING SOFTWARE


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"After the implementation of DOCmanager and due to the parent-child-concept, expenditure of time for an international dossier rollout has dropped from 6 months to 1-2 months"

Director, Regulatory Informatics and Submission Management at Merck Serono

Learn more about EXTEDO DOCmanager

"eCTDmanager´s incredibly user-friendly interface and intuitive design enabled us to operate without dedicated IT support. The EXTEDO team was remarkably supportive, effective and professional throughout our cooperation!"

Regulatory Affairs Director at Guangzhou Henovcom Bioscience Co. Ltd

Learn more about EXTEDO eCTDmanager

"EXTEDO is a great example of a company that really understands the requirements of the market"

Director Business Development, Technical Operations and International Business at Genericon

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"Since the EXTEDO solution is easy to use the training process went smoothly. We were working on compiling dossiers almost immediately after the installation."

Quality Assurance & Regulatory Affairs Manager at PHF SA

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The EXTEDOsuite for Regulatory Information Management and eCTD

EXTEDO‘s focus is on optimizing clients‘ eRegulatory business processes. The EXTEDOsuite is unique in that it covers the complete regulatory landscape.

SOLUTIONS FOR LARGE COMPANIES


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SOLUTIONS FOR SMALL COMPANIES


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SOLUTIONS FOR REGULATORY AGENCIES


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Latest Blog Posts

The Drivers and Benefits behind eCTD 4.0

In recent years, a lot has happened surrounding the development and evolution of the eCTD standard. You have probably already sat through an eCTD 4.0...

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The EMA prepares itself for Brexit

The European Medicines Agency (EMA) recently released a business continuity plan dealing with the potential implications of Brexit. Currently based in...

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The Chinese Food & Drug Administration moves to eCTD

As of 2018, the Chinese Food & Drug Administration (CFDA) has announced that eCTD will become mandatory for electronic submissions within China. Life...

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Latest Events

eCTD Submissions - Practical solutions for managing global regulatory requirements and new challenges

Global regulatory agencies are committed to implementing the eCTD as standard. Attend this practical 2-day course and ensure your applications are in...

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PRA (Professionals Regulatory Affairs Team) eCTD Training

Register soon to get your seat!

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免费网络研讨会: eCTD介绍之旅

中国食药监机构已经宣布,将在2018年开始强制实施eCTD格式的电子递交。eCTD最初是由ICH提出,目前是世界上许多国家作为药物注册申报的标准。为了能够在中国药检机构实施eCTD格式时做好充分地准备和竞争力,现在2017年9月28日下午2点,足不出户,网络线上会议将为带来一次免费的eCTD的介绍之...

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TOPRA Annual Symposium

Meet the EXTEDO team at booth no. 5!

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Regulatory Information Management System (RIMS) Roundtable

In combination with the Werum User Group Meeting in Lüneburg, Germany - register now free of charge!

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