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
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’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.
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 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.
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.
Customer retention over the last five years
Of all eCTD-accepting authorities worldwide are using EXTEDO solutions or services
Faster submission compilation due to intelligent automation
Submissions managed with EXTEDO solutions
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Get a free consultation
Our experienced business and technical team will outline a solution to solve your challenges
Minimise compliance risks
Ensure information accuracy and compliance through efficient digital processes
Latest Blog Posts
DIA 2023 Global Annual Meeting
Meet the EXTEDO team at the DIA 2023 Global Annual Meeting in Boston
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.