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
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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.

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Our Platform Software Solutions

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Document Management Hub

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Registration Management Hub

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Safety Management Hub

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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.

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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.

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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.

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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

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Schedule a call

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

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Get a free consultation

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

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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

Novartis
EUROPEAN MEDICINES AGENCY
Galapagos
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BBRAUN
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Latest Blog Posts

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Bertelsmann Investments Announces Another Major Investment in the Growing Pharma Tech Market

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Interview: Meet EXTEDO’s Regulatory Intelligence (RI) Module!

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Optimizing Life Sciences: EXTEDOpulse powered by CARA Unleashes the Power of Master Data Management in Regulatory Information Management (RIM)

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Upcoming Changes in eCTD EU Module 1 Specification

Upcoming Events

Lisbon, Portugal | April 9, 2024 09:00

Generis Generate 2024

We're already looking forward to joining this great event of our esteemed partner Generis to have fruitful discussions and some quality networking together with other professionals in the Life Sciences Industry.

Dubai , UAE | April 22, 2024 09:00

Join us at the GCC Pharma Summit 2024!

Join EXTEDO's pre-conference eCTD Workshop and presentation at the GCC Regulatory Affairs Pharma Summit 2024 in Dubai.