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. 

OUR AGENCY CUSTOMERS

 

Regulatory Information Management (RIM) Software Solutions and Services

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 SOFTWARE


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PHARMACOVIGILANCE AND DRUG SAFETY SOFTWARE


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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

"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

"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

"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

The EXTEDOsuite for Regulatory Information Management

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 News

Bring Your Boss to eRA and Save 900 €

With attendees from around the globe coming from both industry and regulatory authorities, this year's eRA event promises to be the networking...

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EXTEDO Announces New Regional Partnership with Rephine Balticum for the Baltic and CIS region

Munich / Ottobrunn, Germany – March 30, 2016 – EXTEDO, a leading provider of Regulatory Information Management solutions to the life sciences...

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EXTEDO's Support for eCTD 4.0 (RPS)

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Latest Events

Global eCTD - electronic Dossier & eSubmission

This seminar will address peculiarities in developing and submitting an eCTD within the ICH region as well as in worldwide eSubmisssion requirements.

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eSubmission, IDMP, SPOR & eCTD

(This event will be in German) Diesen eSubmission- und Datenbankverpflichtungen müssen Sie 2017 nachkommen...

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FDA Open Seminar 2017: Opportunities ahead

We are excited to announce the 4th edition of our FDA OPEN SEMINAR!

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DIA Annual 2017

Visit us at booth 612!

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So machen Sie Ihre Altdossiers effizient eCTD-ready!

(This event will be in German) Jetzt müssen für alle europäischen Zulassungsverfahren die Dossiers im eCTD vorlegen - in diesem Seminar lernen Sie...

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