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 FDA’s OPDP eCTD is now in effect - what does it mean for you?
Providing Regulatory Submissions in Electronic and Non-Electronic Format - Promotional Labeling and Advertising Materials for Human Prescription…
OMS to become mandatory for all submissions to EMA
From 1st of October 2021, applicants will have to to use the OMS to register with the EMA for medicinal products
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…
Complimentary Webinar: Advanced eCTD Dossier Handling: Parallel Creation And Progressive Export Of Submissions
Join us to learn how the parallel creation of submissions and an incremental export could improve your regulatory processes.Read more
Complimentary Webinar: EXTEDO's Support Offerings & Best Options To Get In Touch With Us
We invite you to our complimentary webinar on our support offerings and what are the best options to contact our support team.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