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
extedo-dot-grid

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.

Our Regulatory Information Management Software Solution Suite

Learn more about Registration Management Hub
Learn more about Submission Management Hub

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.

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.

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.
>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

icon-placeholder
1

Schedule a call

Choose a time to meet. We’ll discuss your goals and uncover your challenges
icon-placeholder
2

Get a free consultation

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

Logo: Novartis
Logo: European Medicines Agency
Logo: Septodont
Logo: Kern Pharma
Logo: B Braun

Latest Blog Posts

Upcoming events

Webinar: Regulatory Outlook 2026: The Road Ahead for eCTD, IDMP & eP

2026 will bring significant changes for eCTD, IDMP, and ePI requirements across the globe. In this live webinar, we’ll look ahead together and explore what’s coming, what it means for you, and how to navigate the road ahead with confidence.

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.