About EXTEDO

When life science organizations release a new drug or medicinal product into the market, they are legally bound to adhere to regulatory submission and patient safety standards. These requirements can be complicated, and compliance is almost always time consuming and expensive.

EXTEDO makes pharmaceutical compliance an effortless process. We provide solutions and expert knowledge that help life science organizations worldwide to reduce the time and effort required to create and submit regulatory applications for medicinal products and maintain them throughout their lifecycle.

Founded in 1996 as a department within the IABG Group, EXTEDO quickly expanded across the world, bringing the very best in eRegulatory services and solutions. Today, we focus on five core areas required for medicinal product lifecycle management: planning and tracking, document management, product registration, submission management, and safety management.

Our long history of success within the life sciences industry spans 5 product hubs, 60 countries, and over 850 customers.

EXTEDO has also become the trusted solution provider for regulatory authorities such as the European Medicines Agency, most local European National Competent Authorities, Swissmedic, and other regulatory agencies worldwide. With innovation and openness being part of our culture, many of our team also play leading roles within local standards committees and the ISO group, defining standards worldwide.

EXTEDO strives to combine industry-leading innovation with compliance and quality with usability. Through our next-generation products and innovations, we enable life science companies to focus on what’s important - delivering high quality medicinal products such as vaccines that improve lives for millions of people worldwide.

It is our mission to help life sciences organizations ensure compliance with industry standards and regulatory requirements. Our Effortless Compliance™ solutions enable agencies, Clinical Research Organizations, and life sciences organizations worldwide to bring new products to market faster and safer.

EXTEDO understands the complexities of the regulated pharmaceutical product journey. The development of highly complex pharmaceutical products requires accuracy, consistency, efficiency, and quality across all business processes.

Our range of applications and services can be operated alone or implemented together, creating a complete solution for life science product submission and monitoring. Our solutions provide templates, forms, tailored modules, and other assets that enable life sciences organizations to produce, validate, and submit regulatory documentation effectively and efficiently.