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We are grateful to those industry and authority customers who are currently using EXTEDO solutions to help in the fight against COVID-19. It makes us proud to be part of a faster way back to normality.

eCTDmanager Generates Valid EAEU Test Submission

EXTEDO’s EAEU test submissions generated with eCTDmanager have been tested and validated using the agencies' validators. EXTEDO not only offers EAEU in our software eCTDmanager, we can also offer publishing services and can build the submission for you.

eCTDmanager Publishing Services

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 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

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 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

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

Learn more about EXTEDO eCTDmanager

"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

Learn more about EXTEDO

"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

Learn more about our training offerings

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

EU IDMP Implementation Guide Version 1 Released

The European Medicines Agency (EMA) has recently published Version 1 of the EU IDMP Implementation Guide that aims to inform stakeholders about the…

The EMA announces that E2B(R3) will become mandatory from 30 June 2022

In January 2020, the EMA’s management board announced that the use of E2B(R3) will become mandatory as of 30 June 2022.

3 Vital Cloud Migration Considerations

This blog has been formulated to help guide you on your transition to the cloud and to assist you in finding the ideal cloud provider for your…

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