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

EU Medical Device Regulation 2020 - What You Need to Know

On 26 May 2020, the new EU Medical Device Regulation and the EU In-vitro Diagnostics Devices Regulation will come into effect. This blog post will...

Pharmacovigilance in a No-Deal Brexit Scenario

In this blog post we highlight the most important changes to be wary of in the case of a no-deal Brexit, according to the UK government.

Mandatory Use of eCTD For New DMF Submissions in Canada

From 01 September 2019, Health Canada will only accept new DMF applications submitted in eCTD format to enable a common submission intake process as...

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Latest Events

Complimentary Webinar: US FDA Grouped Submissions - Agency Requirements and Best Practices for Submission Management

EXTEDO invites you to its complimentary webinar "US FDA Grouped Submissions - Agency Requirements and Best Practices for Submission Management".

RAPS Regulatory Convergence 2019

Meet the EXTEDO team at booth #303

SIGESTIC 2019

La Empresa de Tecnologías de la Información (ETI) del Grupo de las Industrias Biotecnológica y Farmacéutica de Cuba (BIOCUBAFARMA), convoca a la...

Epista Knowledge & Network Day 2019

Join the Epista Knowledge & Network Day 2019 to turn Life Science obstacles into opportunities. Professionals in quality, regulatory, IT, production,...

EXTEDO & VtR Regulatory Best Practices Workshop

EXTEDO and VtR invite you to their joint Regulatory Best Practices Workshop on 25 September 2019 in Taipei, Taiwan. During the workshop, we will talk...

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