Pharmacovigilance and Drug Safety

EXTEDO’s Pharmacovigilance and Drug Safety solution enables you to classify, create, review, submit, and maintain regulatory pharmacovigilance data and adverse event reports.

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Planning and Tracking

EXTEDO’s Planning and Tracking tools enable you to efficiently plan and track the regulatory data, activities, processes, submissions and commitments related to your entire product portfolio.

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Manage your Registrations

MPDmanager is EXTEDO’s comprehensive XEVMPD and IDMP database system delivering a single source of truth for all IDMP data and enables you to manage and maintain XEVMPD and IDMP data efficiently.

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Submission Management

EXTEDO’s Submission Management tools provide you with a safe and compliant publication & management solution for your electronic and paper based submissions.

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The EXTEDOsuite for Regulatory Information Management

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

PRODUCT REGISTRATION / IDMP


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SUBMISSION MANAGEMENT


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PHARMACOVIGILANCE AND DRUG SAFETY


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PLANNING AND TRACKING


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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

"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

Regulatory Information Management Solutions

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 AGENCIES


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Latest News

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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European eCTD Module 1 v3.0: What to expect & how to prepare?

The final version of EU eCTD Module 1 version 3.0 (eCTD M1 v3.0) will become mandatory on 1st October 2016. During a transitionary period, concluding...

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EXTEDO's Support for eCTD 4.0 (RPS)

EXTEDO Announces New Regional Partnership with the United Arab Emirates Ministry of Health

EXTEDO will be partnering with the Ministry of Health to support the standardization of the electronic submission management process within UAE as...

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eCTDmanager DashBoard is now available

The effortless way to monitor the progress of your electronic submissions

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Latest Events

Seminar: So machen Sie Ihre Altdossiers effizient eCTD-ready!

NTA, CTD, eCTD - Ihre Schritte bis 1.1.2017

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Complimentary Webinar: Cloud Content Management and Publishing - Delivering Value and Efficiency

EXTEDO invites you to its Complimentary Webinar "Cloud Content Management and Publishing - Delivering Value and Efficiency".
Join this webinar to see...

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Webinar: Updates of ASMF Submission Rules - How to easily create eCTD ASMFs in EXTEDO´s DOCmanager

eCTDmanager User Group Meeting 2016 and Training Course

This event provides an unique opportunity for EXTEDO users to meet and exchange information and experiences among each other and with the EXTEDO...

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PcVmanager User Group Meeting 2016 and Training Course

This event provides an unique opportunity for EXTEDO users to meet and exchange information and experiences among each other and with the EXTEDO...

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Complimentary Webinar: Pharmacovigilance Inspection Readiness in Spain: Electronic Safety Database

EXTEDO and ASPHALION invite you to their webinar "Pharmacovigilance Inspection Readiness in Spain: Electronic Safety Database".

During the webinar...

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Complimentary Webinar: The Updated Version of the ISO IDMP Standard

EXTEDO invites you to its webinar "The Updated Version of the ISO IDMP Standard".

On the 6th of May, ISO TC 215 health informatics will decide on the...

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Complimentary Webinar: The New Draft Version of the ISO IDMP Standard

During the last couple of months, the IDMP expert team at ISO has intensively worked on the revision of the IDMP standard and the finalization of the...

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Complimentary Webinar: EXTEDO EURSvalidator - Preparing for the European eCTD Module 1 Version 3.0 Specifications

The EMA has announced that the new eCTD Module 1 version 3.0 standard will become mandatory on 1st October 2016. To help you prepare and understand...

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