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 five 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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Planning & Tracking Hub

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Document Management Hub

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Product Registration 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 small companies

EXTEDO provides solutions covering the entire regulatory landscape. Through this unique approach EXTEDO supports small 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

Our Customers

Novartis
EUROPEAN MEDICINES AGENCY
Merck
SANOFI
Heel
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Latest Blog Posts

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The EMA published the FHIR Conceptual Data Model (CDM)

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US FDA Adverse Event Reporting System (FAERS) Electronic Submissions

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EMA Publishes New Timeline For DADI Project

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US FDA Adopts ICH Clinical Trials Guideline with Exclusive Reference to E2B(R3) Standards

Upcoming Events

Boston, USA | June 25, 2023 00:00

DIA 2023 Global Annual Meeting

Meet the EXTEDO team at the DIA 2023 Global Annual Meeting in Boston

Munich, Germany | July 5, 2023 08:30

eRA 2023 Conference

Join us for eRA 2023, a unique learning and networking opportunity for regulatory, safety and quality professionals from around the globe. Our packed program will offer insights and the latest developments in the global regulatory landscape, with presentations from industry and authority thought leaders.