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
Australia readies itself for eCTD only
Starting 1st November Australia’s TGA will begin the transition to eCTD format only for all prescription medicine. Find out which products will be…
China NMPA will be accepting eCTD submissions from 29th December 2021
eCTD submissions will be accepted by China NMPA as an optional submission format by end of 2021.
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…
EXTEDO, GGA & TRPMA Workshop - Global Regulatory Trends & eCTD 4.0
Register now for our joint workshop with TRPMA and GGA in Taipei!Read more
Complimentary Virtual Event: EXTEDO Innovation Day
The future starts now – Envision your ultimate medicinal product journey!Read more
Complimentary Virtual Event: EXTEDO Innovation Day for Agencies
This event is limited to delegates from regulatory authorities.Read more