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.
Regulatory Affairs Director at Guangzhou Henovcom Bioscience Co. Ltd
Director Business Development, Technical Operations and International Business at Genericon
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.
EXTEDO helps large life sciences companies navigate the complex regulatory landscape involved with developing and managing hundreds of products across multiple geographic regions.
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.
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
The Mystery of the EU IG - Insider Perspective
Anjana Pindoria is part of EXTEDO’s product management team and a member of the EU Telematics group, after working 9 years for pharmaceutical…
Therapeutic Goods Administration (Australia) to transition all regulatory submissions to eCTD-only, starting in 2021
MHRA Publishes New Guidance for Converting Centrally Authorized Products to UK Marketing Authorizations
UK’s Medicines and Healthcare products Regulatory Agency (MHRA) publishes new guidance on how to convert an existing Centrally Authorized Product…
EU IDMP Implementation Guide Version 1 Released
The European Medicines Agency (EMA) has recently published Version 1 of the EU IDMP Implementation Guide that aims to inform stakeholders about the…
Complimentary Webinar: US FDA: Cross Application References / Hyperlinks / Bookmarks (CAR/CAH/CAB)
Register now for our complimentary webinar on US FDA: Cross Application References / Hyperlinks / Bookmarks (CAR/CAH/CAB)Read more
Complimentary Webinar: The Basics of EAEU Submissions and Special Requirements for Russia, Belarus and Kazakhstan
Register now free of charge to learn about EAEU Submissions and special requirements for Russia, Belarus and Kazakhstan.Read more
Complimentary Webinar: The Basics of eCTD Submissions in South Africa
We invite you to our complimentary webinar sharing the basics of South African eCTD submissions, which will be mandatory soon.Read more