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
US FDA Adopts ICH Clinical Trials Guideline with Exclusive Reference to E2B (R3) Standards
US Food & Drug Administration announced that they adopted the ICH E8(R1) guideline on general considerations for clinical studies.
CMDh Updates Guidelines to Implement Northern Ireland Protocol (Brexit relevant information)
Updated practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DC
US FDA announces that DTD version 3.3 will be made mandatory for eCTD submissions
US FDA announced the requirement for Electronic Common Technical Document (eCTD) Module 1 U.S. Regional DTD Version 3.3 starting from 01 March 2022.
Use of E2B(R3) Becomes Mandatory June 2022 - How to Prepare
In January 2020, the EMA’s management board announced that the use of E2B(R3) will become mandatory in production as of 30 June 2022.
EU Clinical Trials Regulation Now in Effect
The EMA released the new Clinical Trials Regulation, replacing the Clinical Trials Directive on 31 January 2022.
EMA Updates Technical Guidance for eCTD Submissions in the EU
The European Medicines Agency (EMA) has published version 5.0 of its Harmonized Technical Guidance for eCTD Submissions in the EU on 17 December 2021.…
Complimentary Webinar: The Impact of the Brexit on Pharmaceutical Companies and their Regulatory Departments
This webinar will show you which changes have been made with Brexit and what new changes have been introduced by MHRA and CMDh recently.Read more
Complimentary Webinar: The Importance of Effortless Master and Core Product Data Management
How to boost your efficiency in managing your product lifecycle!Read more
Chicago, IL, USA
DIA Global Annual Meeting 2022
Meet EXTEDO in the exhibition area at booth #2552!Read more