EXTEDO eCTDmanager User Group Meeting for North America

Join us at our upcoming eCTDmanager Training and User Group Meeting on 21/22 March 2018 in Philadelphia! Learn about the latest product and regulatory roadmaps, eCTD 4.0 and get tips and tricks which will make your work easier. Discuss and network with your peers and the EXTEDO team on site. Register now for one of two training courses and/or the User Group Meeting! 

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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

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"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

eSubmission Roadmap: The Decline of NeeS & the Roadmap to eCTD

Historically, within the EU dossiers for medicinal products marketed for humans could be submitted in two electronic formats: NeeS (Non-eCTD...

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The European Medicines Agency (EMA) comes to Amsterdam

The Dutch bid won the tender through draw. Amsterdam defeated Milan and fourteen other entries.

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eCTD 4.0: What's new in the Granularity Update?

On October 4th, I found yet another section of the FDA’s website to look at – the ICH Interdisciplinary guidance. That day the FDA released its...

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Understanding eCTD Submissions: the impact on your company

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DIA Regulatory Submissions, Information, and Document Management Forum (RSIDM) 2018

Meet EXTEDO in the exhibition area at booth no. 200!

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EXTEDO eCTDmanager North American User Group Meeting / Training

Register now for our upcoming North American User Group Meeting on 22 March and/or the training courses on the day before!

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DIA Europe (30th Annual EuroMeeting) 2018

Meet EXTEDO in the exhibition hall at booth no. 65!

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Informa eRegulatory Summit 2018: Global eCTD Management / Regulatory Information Management and IDMP Compliance

Save 25% with the EXTEDO promotion code and meet the EXTEDO experts in the exhibition area!

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