Home | EXTEDO

Streamline regulatory information management processes with effortless compliance

Software and expertise to efficiently manage your regulated data, documents and processes within the life science industry.

Faster time-to-market for life-saving medicinal products

Automate processes in a complete Regulatory Information Management System

Compliance with regulatory standards around the world

How much time are you wasting on managing regulatory information?

Effectively managing documents, data and processes in compliance with varying regulatory standards around the world is complex and time-consuming.

I am worried about people working in disconnected silos
I am concerned about the increasing amount of information that needs to be managed
I am worried about not meeting deadlines
I don’t fully understand regulatory processes

We are not ready for future regulatory changes
We don’t have the right internal skills or knowledge
I am concerned about the inefficiency of paper-based processes
Our current processes impede our ability to grow and get to market first

Managing regulated information should be effortless

EXTEDO’s end-to-end RIM platform consists of different hubs that address every step of medical product development. Use the applications individually or gain additional value by using them together based on your requirements.

Streamline your regulated processes

Managing documents, data and processes in compliance with regulatory standards around the world is time-consuming and costly for all life sciences organizations.

EXTEDO provides the tools and expert knowledge needed to effortlessly manage regulatory information; enabling you to minimize compliance risks and get medicinal products to market faster.

Solutions for large companies

EXTEDO helps large life sciences companies navigate the complex regulatory landscape involved with developing and managing hundreds of products across multiple geographic regions.

Read more

Solutions for SMBs and CROs

EXTEDO provides solutions covering the entire regulatory landscape. Through this unique approach, EXTEDO supports small/medium-sized companies and CROs with off-the-shelf software and services designed around common business and regulatory needs.

Read more

Solutions for regulatory agencies

For many years EXTEDO has collaborated with regional agencies to ensure compliance with the latest regulatory standards. Our reviewing and validation solutions are used by over 35 regulatory agencies worldwide.

Read more

>98%

Customer retention over the last five years

>70%

Of all eCTD-accepting authorities worldwide are using EXTEDO solutions or services

>50%

Faster submission compilation due to intelligent automation

>1M

Submissions managed with EXTEDO solutions

Your plan to effortless compliance

1

Schedule a call

Choose a time to meet. We’ll discuss your goals and uncover your challenges

2

Get a free consultation

Our experienced business and technical team will outline a solution to solve your challenges

3

Minimise compliance risks

Ensure information accuracy and compliance through efficient digital processes

For over 25 years EXTEDO’s regulatory information management (RIM) solutions have been used by industry and agencies worldwide to streamline the process of managing regulated information.

"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

Some of our Customers

Upcoming events

Webinar 26 February 2026

Webinar: China eCTD v1.1 Unpacked: The Real Impact of the 2026 Update

China’s upcoming eCTD v1.1 update is set to reshape submission processes. Join our experts as they break down what’s changing, what it means for your organization, and how to prepare now to stay ahead. This live webinar will give you clarity on timelines and requiements, plus a sneak peek into our Submission Management Hub in action.

Webinar 05 March 2026

Webinar: The eCTD v4 Upgrade: End-to-End Publishing, Transition & Conversion Services

Regulatory deadlines are fixed, but eCTD v4 introduces new complexity and workload for submission teams. Join our Publishing Services experts to learn how dedicated eCTD v4 publishing support ensures compliant, on-time eCTD v4 submissions, e.g. to EMA or the US FDA.

See more events