Regulatory Information Management & eCTD Software Solutions and Services for Life Sciences

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.

Planning & Tracking Hub

Document Management Hub

Product Registration Hub

Submission Management Hub

Safety Management Hub

"eCTDmanager´s incredibly user-friendly interface and intuitive design enabled us to operate without dedicated IT support. The EXTEDO team was remarkably supportive, effective and professional throughout our cooperation!"

Regulatory Affairs Director at Guangzhou Henovcom Bioscience Co. Ltd

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"EXTEDO is a great example of a company that really understands the requirements of the market"

Director Business Development, Technical Operations and International Business at Genericon

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"Since the EXTEDO solution is easy to use the training process went smoothly. We were working on compiling dossiers almost immediately after the installation."

Quality Assurance & Regulatory Affairs Manager at PHF SA

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EXTEDOpulse for Regulatory Information Management and eCTD

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.

Solutions For Large Companies

EXTEDO helps large life sciences companies navigate the complex regulatory landscape involved with developing and managing hundreds of products across multiple geographic regions.

Solutions for Small Companies

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.

Solutions for Regulatory Agencies

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 Food & Drug Administration announced that they adopted the ICH E8(R1) guideline on general considerations for clinical studies.

Updated practical guidance for procedures related to Brexit for medicinal products for human use approved via MRP/DC

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.

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.

The EMA released the new Clinical Trials Regulation, replacing the Clinical Trials Directive on 31 January 2022.

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.…

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Upcoming Events

Webinar 2022-05-17

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.

Webinar 2022-05-24

Complimentary Webinar: The Importance of Effortless Master and Core Product Data Management

How to boost your efficiency in managing your product lifecycle!

Chicago, IL, USA 2022-06-19

DIA Global Annual Meeting 2022

Meet EXTEDO in the exhibition area at booth #2552!

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Regulatory Information Management & eCTD Software Solutions and Services for Life Sciences

Planning & Tracking Hub

Document Management Hub

Product Registration Hub

Submission Management Hub

Safety Management Hub

"eCTDmanager´s incredibly user-friendly interface and intuitive design enabled us to operate without dedicated IT support. The EXTEDO team was remarkably supportive, effective and professional throughout our cooperation!"

"EXTEDO is a great example of a company that really understands the requirements of the market"

"Since the EXTEDO solution is easy to use the training process went smoothly. We were working on compiling dossiers almost immediately after the installation."

EXTEDOpulse for Regulatory Information Management and eCTD

Solutions For Large Companies

Solutions for Small Companies

Solutions for Regulatory Agencies

Latest blog posts

US FDA Adopts ICH Clinical Trials Guideline with Exclusive Reference to E2B (R3) Standards

CMDh Updates Guidelines to Implement Northern Ireland Protocol (Brexit relevant information)

US FDA announces that DTD version 3.3 will be made mandatory for eCTD submissions

Use of E2B(R3) Becomes Mandatory June 2022 - How to Prepare

EU Clinical Trials Regulation Now in Effect

EMA Updates Technical Guidance for eCTD Submissions in the EU

Upcoming Events

Complimentary Webinar: The Impact of the Brexit on Pharmaceutical Companies and their Regulatory Departments

Complimentary Webinar: The Importance of Effortless Master and Core Product Data Management

DIA Global Annual Meeting 2022

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