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
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.…
MHRA updates Guidance for Centrally Authorized Products (CAPs) to UK Marketing Authorization (MAs)
The Medicines and Healthcare products Regulatory Agency (MHRA) has updated its Guidance for CAPs with further information on the submission process…
New EU Guidance on Data Submission for Investigational Medicines
On October 20th, 2021, the EMA released guidance on the submission of information on investigational medicinal products for human use in the xEVMPD.
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…
North Bethesda, MD, USA
DIA Regulatory Submissions, Information, and Document Management Forum (RSIDM) 2022
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Informa Global Pharmaceutical Regulatory Affairs Summit (GPRAS) 2022
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Chicago, IL, USA
DIA Global Annual Meeting 2022
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