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 EMA published the FHIR Conceptual Data Model (CDM)
Updated excel file now available on the DADI website
US FDA Adverse Event Reporting System (FAERS) Electronic Submissions
Is the US Food & Drug Administration in final preparations for switching to E2B(R3)?
EMA Publishes New Timeline For DADI Project
Updated DADI Human Variations Form Timeline and revised go-live scope
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.