EXTEDOpulse - A Comprehensive Regulatory Information Management Software Solution for Life Sciences
EXTEDOpulse is a comprehensive RIM software solution that addresses every step of pharmaceutical product development. Use the applications individually or gain additional value by using them together based on your requirements.
Developing pharmaceutical products can be a multi-faceted process, involving input and efforts from across an organization. The complexities of operating within a highly regulated industry only further compound the challenges that a life science organization faces with every release. Having our finger on the pulse of the life sciences anatomy allows us to provide you with great synergy, connection and innovation for effortless compliance. Ever-changing regulatory requirements demand maximum flexibility, which we achieve through continuous process improvement and the integration of advanced technologies such as artificial intelligence (AI). EXTEDOpulse has been designed with these aspects in mind to help you connect the dots throughout the entire lifecycle of pharmaceutical products.
EXTEDO understands the complexities of the regulated pharmaceutical product journey. From drug development, to market launch and pharmacovigilance surveillance, EXTEDOpulse is the right solution from the start, for every step. With EXTEDOpulse, the flexibility for better solutions is in your hands. Created from direct feedback and the needs of life science organizations, EXTEDOpulse introduces next-level automation to optimize your team’s productivity across every aspect of development.
Our Software Solutions
Quality Management Hub
Submission Management Hub
Safety Management Hub
Request your personal EXTEDO Software Demo now!
Benefit from end-to-end Master Data Management in EXTEDOpulse
The EXTEDOpulse Master Data Management acts as the base layer, seamlessly connected to externally controlled vocabulary repositories such as SPOR, while serving as a virtual resource for all EXTEDOpulse business hubs. The MDM serves as the central repository for maintaining reusable data at a single source of truth.
Utilizing master data across the regulatory information management process in EXTEDOpulse offers significant advantages. By reusing data, consistency is maintained across all Hubs, significantly reducing the potential for errors. This approach ensures that everyone is working with the same data, streamlining operations and enhancing accuracy. With a unified data set, regulatory compliance becomes more straightforward, and decision-making is based on reliable, consistent information. This not only boosts efficiency but also increases the reliability of the regulatory outcomes.
Registration Management Hub
Document and Content Management Hub
Quality Management Hub
Submission Management Hub
Safety Management Hub
Effortlessly Streamline Your Workflow with Automated Triggering of Applications and Sequences
Using EXTEDOpulse streamlines your submission process with key features like in-progress viewing exports, parallel publishing and reviewing, and efficient submission content planning and tracking. Easily use your submission content plan from the Document Management Hub in the submission structure with drag-and-drop functionality. Synchronize content plans, trigger initial applications and follow-up submissions, and access submission deep links from the Submission Management Hub in the Registration Management Hub.
This approach allows the application to be created once and reused within EXTEDOpulse, reducing time and enhancing data quality and consistency. Triggering the sequence creation directly from the Registration Management Hub with automated links provides easy access from various functional views and ensures a streamlined and efficient workflow.
Learn more about the EXTEDOpulse Subscription Plans
Some of our Customers
Services
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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.
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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.
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Regulatory Publishing Services
With agencies required to produce ever more submissions in electronic formats, the cost and effort involved in converting paper-based documentation into eCTD, and other electronic formats, and publishing them to the authorities can be prohibitive for many smaller life sciences organizations.
