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Regulatory Information Management & eCTD Software Solutions and Services for Life Sciences
EXTEDOpulse supports the critical relationship between the pharmaceutical industry and regulatory authorities, ensuring that your life sciences business operates a compliant and efficient product registration and maintenance process.
Planning & Tracking Hub
Document Management Hub
Product Registration Hub
Submission Management Hub
Safety Management Hub
EXTEDOpulse for Regulatory Information Management and eCTD
EXTEDO‘s focus is on optimizing clients‘ eRegulatory business processes. EXTEDOpulse is a complete Regulatory Information Management System (RIMS), including Planning & Tracking, Document Management, Product Registration, Submission Publishing & Lifecycle Management, and Safety Management.
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.
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Upcoming Events
Webinar
Complimentary Webinar: The Reuse of Data - How to use eCTDmanager more efficiently
In this webinar, you will learn more about using specific functionalities within eCTDmanager to reuse data and documents when managing multiple…
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Info Market: Digital RA & QM-Solutions
Whether it's technical documentation or risk assessment, how would it be if tasks like these could be completed faster and more efficiently?
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Complimentary Webinar: Implement a Master Quality Management System: How can you eliminate uncertainty and prepare stakeholders?
Life sciences organizations need to balance easy access to data, fast internationalization and operational efficiency with product quality and risk.…
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