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.
Latest blog posts
Upcoming Events
Webinar
Complimentary Webinar: OPDP in eCTD Format
From 24 June 2021, OPDP / Ad-Promo submissions to the US FDA have to be submitted in eCTD format, using the latest DTD 3.3. These submissions are…
Read moreVirtual Event
European Regulatory Affairs Forum 2021
Pharma Education Center (PEC) warmly invites Regulatory Affairs professionals from Pharma Companies to join the next edition of the “European…
Read moreWebinar
Complimentary Webinar: VNeeS Veterinary Submissions & The Significant Changes Coming With The New Veterinary Regulation
Register for our free webinar on veterinary submissions
Read moreEXTEDO is committed to follow the highest standards on Data Protection.
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