Agency | EXTEDO

EXTEDOpulse for Agencies: Seamlessly Manage Health Authority Information from End-to-End

Boost Collaboration and Communication with Stakeholders
Transform Your Agency’s Management of Regulatory Information
Streamline Regulatory Processes for Future-Proof Compliance

Do you feel prepared for the digital challenges of the future?

Processing an increasing amount of data on time during submission reviewing while keeping up with regulatory requirements is daunting.
  • I am pressured to reduce reviewing time and comply with procedural timelines
  • I am overwhelmed by the number of places where data is stored
  • I am frustrated because documents are stored in different formats and versions in multiple data silos
  • I struggle identifying changes within the lifecycle of submissions
  • The number and complexity of incoming cases is constantly increasing
  • We’re struggling with a complex infrastructure and need automation
  • It is not easy to stay up to date with regulatory requirements as they often change and develop
  • I struggle to manage, communicate and share information with applicants efficiently

The right partner on your way to regulatory excellence 

EXTEDO is your trusted partner for end-to-end solutions and services to transform the regulatory processes of health agencies. Resulting from a long and fruitful collaboration, our offering is convincing: We proudly serve most European agencies including the EMA and are the choice of over 35 regulatory agencies worldwide.

Request your personal EXTEDO Software Demo now!

Enhance bi-directional collaboration with EXTEDO's agency portal

EXTEDO’s agency portal allows registered pharmaceutical companies to easily upload their submissions. Extensions or variations can be requested at any time. Status information or other feedback is provided through the same channel as the only means of communication. 

Streamline submission reviews with automated workflows and lifecycle transparency

Automated workflows reduce both reviewing time and the probability of errors. Data that has been stored in different silos is combined into a smooth stream that flows through different processes, ensuring transparency at every stage of the lifecycle. This enables precise content comparison and validation and allows to easily track submission changes. You maintain full control over submission quality, streamlining the review process for greater efficiency and compliance.

Find all your documents in one place for more efficient reviewing

Monitor and manage submission documents seamlessly to ensure regulatory processes run smoothly and efficiently. By centralizing document storage, you can locate the right document quickly and always access the latest version. Silos are eliminated, and review processes are accelerated. Stay on top of the submission document’s status across the entire agency! 

Ensure compliance and accuracy in product registration data

Easily manage incoming product registration data in one single source of truth, ensuring compliance with evolving regulatory requirements. Built-in validation guarantees data accuracy, while complex processes are streamlined to gain full visibility into marketing authorizations.

Some of our customers