Efficiently validate submissions by predefining requirements

Ensure that medicinal products meet regulatory requirements

Scale your processes with parallel work between multiple users

How much time do you spend assessing submissions?

Reviewing large volumes of data for compliance takes a lot of time without dedicated tools and processes.

  • I’m pressured to reduce reviewing time and comply with procedural timelines
  • We’re overwhelmed by the number of submissions to process
  • I’m having difficulties identifying the changes in a submission within its lifecycle
  • I’m frustrated by the lack of collaboration because documents are stored in multiple data silos
  • We’re struggling with a complex infrastructure and are in need of a smarter automation

Validating and reviewing submissions within given timelines should be effortless

Efficient handling

Easily navigate around the structure of a submission in different view modes.


Annotations can be exported easily to speed up the creation of your assessment report.

Validation at scale

Scalable for numerous internal and external users where IT resources may be limited.

Life cycle management

Quick access to submissions throughout the entire lifecycle of a medicinal product.

For over 25 years EXTEDO’s regulatory information management (RIM) solutions have been used by industry and agencies worldwide to streamline the review of regulatory submissions.
"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

Your plan to effortless compliance


Schedule a call

We’ll discuss your goals and uncover your challenges.


Get a free consultation

Our team will analyze your current review processes.


Reduce your assessment timelines

Improve your assessment and validation processes. 

Streamline your submission validation

Regulatory agencies are faced with increasing volumes of submission documents and data. The agency solution lets organizations review electronic submissions in a timely manner, enabling them to avoid backlogs and ensure that medicinal products meet regulatory requirements.


Request your personal EXTEDO Software Demo now!

Integrates effortlessly with third-party software

To ensure a seamless connection to your existing processes, the agency solution provides an API that enables you to readily integrate with many third-party systems. This ensures increased operational efficiency and further streamlines the validation processes within your organization. In addition to this, the agency solutions’ integrated connector enables you to automatically keep a local agency solution repository, or partial repository, that is synchronized with the EMA Common Repository. The in-build technical validation ensures your submission is valid according to the latest validation criteria provided by the authorities.

Easy to deploy, swift to scale

The agency solution is powerful, yet simple to deploy within your agency. Depending on your system specifications, the agency solution can be installed and validated within a matter of days. Its user-friendly and intuitive interface is equipped with integrated, context-sensitive online help that ensures ease of adoption amongst your users and minimizes the need for expensive structured training sessions. Supporting distributed workforces with many hundreds of users, the agency solution is an extremely scalable solution.


Quick access to relevant information by text search and filtering

Through the agency solution interface, you can access imported submissions and search, view, and annotate them. This powerful feature allows you to organize and filter submissions based on certain criteria, such as regulatory activities corresponding to the overall regulatory status of a drug product. As recognized by regulatory authorities around the globe, the agency solution is the requisite solution for effortless review and validation of regulatory submissions.


The efficient user interface

If you need online access to previously submitted electronic dossiers, then EXTEDO’s agency solution is the answer. It provides a fully functional reviewing system for agencies, enabling them to view and review submission data directly within a web browser. With no need for client software, the agency solution is the ideal solution for collaborative working between agency staff and external assessors where IT resources may be limited.


Some of our Customers

Paul- Ehrlich- Institut
State Agency of Latvia

Contact us


Business Process and Regulatory Consulting Services

Tailored specifically to the needs of regulatory and related stakeholders, EXTEDO’s business process and regulatory consulting services are designed to support you during and after your eCTD submissions. Through a series of workshops, our team of experienced consultants will establish your business needs, understand your processes, and help you to define the most appropriate implementation approach.


Education & Training Services

To ensure you get the most out of your purchased solution, we offer detailed training for each product within the EXTEDOpulse solution portfolio. Training sessions are tailored to your individual needs and cover a broad range of technical and regulatory topics. Designed to educate you on how to utilize your EXTEDO solution, our training sessions are conducted either in-house or onsite. 


Technical Consulting

Purchasing a new EXTEDO application is the first step to streamlining business and regulatory processes within your organization. However, ensuring correct installation, implementation and integration is a crucial step in the process of deploying your new solution.


Product Information

EXTEDO EURSnext Product Information

Product Information

EXTEDO EURS Product Information

Resources Preview Pictures _Flyers and Case Studies (1)

EXTEDOpulse Platform Brochure