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
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…
The EMA announces that E2B(R3) will become mandatory from 30 June 2022
In January 2020, the EMA’s management board announced that the use of E2B(R3) will become mandatory as of 30 June 2022.