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

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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

SOLUTIONS FOR SMALL COMPANIES

SOLUTIONS FOR REGULATORY AGENCIES

EMA Officially Endorses the New EudraVigilance System for Adverse Reactions

On May 22, 2017 the European Medicines Agency’s (EMA) management board endorsed the start of the official countdown for the launch of the improved...

Why we believe in IDMP and you should too

The EMA recently announced that they will be delaying the roll-out of the new ISO IDMP standard within Europe until after the completion of the formal...

Health Canada confirms mandatory use of eCTD format from 1st January 2018

From the beginning of next year, Health Canada will only accept submissions for certain regulatory procedures in the electronic common technical...

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Latest Events

ARCS & EXTEDO: Introduction and Best Practices for Electronic Submissions in eCTD Format

This workshop will provide an overview of the history of eCTD, i.e. why we have the standard, the eCTD structure and life cycle management....

2017 ARCS Annual Conference

Meet EXTEDO at booth no. 2!

RAPS - The Regulatory Convergence

Visit us at booth no. 413!

4th Annual ParmaCon Asia 2017

Meet the EXTEDO team at our exhibition table!

PRA (Professionals Regulatory Affairs Team) eCTD Training

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