eSUBmanager Simplifies The Reviewing Of eCTD And Other Electronic Standards

eSUBmanager is a modern SaaS solution, that is designed to facilitate the review of electronic submissions throughout your company and partner network.

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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 Consulting Services

No matter if you need support with converting old NeeS submissions to eCTD, general publishing support, or an expert for stremlining your business processes - EXTEDO's experts can help you.

OUR SERVICES OFFERINGS

Regulatory Software Solutions for a Global Community

EXTEDO enables more than 35 regulatory authorities and 850 maintained customers across 60 countries to deliver Effortless Compliance.

OUR AGENCY CUSTOMERS

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 a top 30 pharma company

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"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

SOLUTIONS FOR SMALL COMPANIES

SOLUTIONS FOR REGULATORY AGENCIES

Updated Version of the HMA eSubmission Roadmap (v2.2) Available

The final version of the HMA eSubmission roadmap has been updated on 21 June 2019.

Technical Validation: A Bottleneck in the Drug Registration Process?

In this article, we go through some of the general technical validation requirements and how to better understand them.

Brexit-related Topics Relevant to Medicinal Product Registration

There are currently many ongoing activities and discussions relating to Brexit and its potential implications across many different sectors.

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Latest Events

BioAsia 2019 Taiwan

The first global biotech event held in Taiwan

ARCS 2019 Annual Conference

Meet our local partner Bio & Gene in the exhibition area!

RAPS Regulatory Convergence 2019

Meet the EXTEDO team at booth #303

TOPRA Annual Symposium 2019

Meet EXTEDO at booth no. 1

5th Pharmacovigilance & Drug Safety Summit

With the goal of making medicine safe for people all over the world, there are few issues more important than drug safety. And while predicting the...

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