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

SUBMISSION MANAGEMENT & eCTD SOFTWARE

PHARMACOVIGILANCE AND DRUG SAFETY SOFTWARE

REGULATORY PLANNING AND TRACKING SOFTWARE

"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

Learn more about our training offerings

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

SOLUTIONS FOR SMALL COMPANIES

SOLUTIONS FOR REGULATORY AGENCIES

Key Concepts Behind eCTD 4.0 and their Impact on Product Submissions

In our introduction to eCTD 4.0 post, we talked about the drivers behind the Next Major Version of eCTD, version 4.0 and its benefits for...

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...

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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Latest Events

Regulatory Information Management System (RIMS) Roundtable

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

“eCTD电子申报及最佳实践操作”高级培训班

如何让最安全、有效和高质量的药品以最经济高效的方式得到批准和上市是药品监管部门、制药企业的共同心愿。从2008年起，FDA开始鼓励以eCTD(electronic Common Technical...

Informa / Knect365: Global Pharmaceutical Regulatory Affairs Summit (GPRAS) 2017

25% discount for EXTEDO customers. Meet the EXTEDO Team in the exhibition area!

The 4rd Symposium of the Construction of Digital Laboratory and Its Applications - Neotrident User Group Meeting

Meet the EXTEDO team there!

Advanced Cell Therapy Shanghai Summit 2017

Meet the EXTEDO Team in the exhibition area!

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