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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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

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

Complimentary Webinar: DMF Submissions for US and EU

From May 5, 2017, all new Drug Master Files (DMFs) submitted to the US FDA, as well as any additional submissions relating to existing DMFs, must be...

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DIA EuroMeeting 2017

Meet us at booth no. E8!

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Informa eRegulatory Summit: Global eCTD Management / Regulatory Information Management (RIM) / Filing Variations

EXTEDO is sponsoring this event, meet us there and save 25% by registering through our link or code.

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EXTEDO eRA 2017 - Regulatory Information Management in the Era of Globalization

Join us at eRA 2017, the Electronic Regulatory Affairs Conference and EXTEDO User Group Meeting on 10-11 May 2017 in Majorca, Spain

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DIA Annual 2017

Visit us at booth 612!

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