Navigate intricate regulations for multiple
products across regions

Connect your team in a single platform and reduce information silos

Minimize compliance risks and accelerate time-to-market

For any large enterprise without a robust RIM solution, navigating the intricate web of regulations governing multiple products across various regions can be a daunting task. At EXTEDO, we understand the challenges you face when it comes to submitting your products to national health authorities. EXTEDO’s comprehensive software suite allows you to connect your entire team on a single platform, eliminating information silos that hinder progress. Compliance risks can pose additional significant hurdles on your journey to market success. Our solutions are designed to minimize these risks while accelerating your time-to-market, ensuring your products reach their destinations efficiently and without delay.

With a remarkable 25-year track record, EXTEDO has been a trusted partner in the life sciences industry. We have proudly collaborated with numerous large enterprises and multinational organizations, tailoring our off-the-shelf software solutions to meet the unique business needs and regulatory requirements of companies and agencies of all sizes.

Let EXTEDO empower your enterprise with the tools and expertise needed to conquer regulatory hurdles and bring your products to market swiftly and confidently. Discover how we can transform your regulatory information management today!

Are your products taking longer to reach market due to regulatory complexities?

Mastering global regulatory tasks in a multinational life science organization requires the right strategies

  • Staying up-to-date with international regulations and new standards is a complex and ongoing concern
  • Allocating and controlling resources efficiently is a constant struggle for me
  • We lack a robust strategic structure to effectively expand and compete in the market
  • I'm dealing with a massive volume of documents and data, which can be overwhelming to manage efficiently
  • I need better ways to handle the increasing volume and size of incoming submissions
  • Collaborating on submissions across different teams and regions can be challenging
EXTEDO is known for the knowledge of the relation with the regulatory agencies. So it was one of our first choices when we decided to move to another vendor.
We know that eCTD 4.0 is coming. We know that EXTEDO is working on that. We know that they are very capable of those situations, so we rely on them.

Ana Verónica Mak, Associate Director of the Publishing Team, Parexel

Some of our Customers

GlaxoSmithKline (GSK)
ICON Clinical Research

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The eDOCSmanager app is a secure document management system for Life Sciences. Regulatory, Clinical (eTMF), Quality and SOP Management Modules are available.



MPDmanager powered by CARA is EXTEDO’s comprehensive XEVMPD and IDMP software solution delivering a single source of truth for all ISO IDMP data. It supports you in planning and tracking of IDMP.


EXTEDO eCTDmanager

Build, view, validate and publish compliant submissions based on CTD, eCTD, NeeS, eCopy, IMPD, CTA, VNeeS, DMF, ASMF, and other submission structures.


EXTEDO eSUBmanager

Reduce the complexity of viewing and reviewing archived and in-progress electronic submissions.


EXTEDO EURSvalidator

Easily validate medicinal and veterinary electronic submissions with the validator that is used by over 35 authorities worldwide, including EMA.


EXTEDO SafetyEasy

Classify, create, review, submit and maintain pharmacovigilance, medical device vigilance, cosmetovigilance and nutrivigilance data and adverse event reports within a single, easy-to-use application.


EXTEDO eCTDtemplates

EXTEDO eCTDtemplates provide a simple way to create consistent and compliant electronic Common Technical Document (eCTD) dossiers.

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