EXTEDOpulse - A Comprehensive Regulatory Information Management Software Solution for Life Sciences
Everything you need to tackle the master data, document, registration, submission and safety management challenges of today.
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.
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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.
Learn more about the EXTEDOpulse Subscription Plans
Master Data Management
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.
Document Management Hub
The EXTEDOpulse Document Management Hub supports you in managing regulatory data and documents throughout the entire submission lifecycle, connecting stakeholders with automated processes, eliminating the need to conduct on-site monitoring visits, managing SOP and related training documents, managing CAPA, audits, documenting deviations, and coordinate change control activities, and ensure consistent authoring standards. With EXTEDOpulse, document management becomes an asset for productivity.
Registration Management Hub
EXTEDO’s Registration Management Hub simplifies the process of capturing and managing IDMP, XEVMPD, and other medicinal product information, delivering a single source of truth for product data. Gain a powerful medicinal product database to manage your registrations for effortless compliance. Improve your data quality, increase operational efficiency, and deliver better-automated communication channels between your departments and with the authorities.
Safety Management Hub
The Safety Management Hub enables you to minimize costs and deliver best-practice monitoring and reporting workflows crucial to your business's success. Create, review, submit and maintain multivigilance data and event reports within a single, easy-to-use application. Its future-proof approach is able to generate PSUR, PBRER, and DSUR documentation and is ready for forth-coming standards such as IDMP.
Submission Management Hub
Efficiently build, view, validate, publish, and review compliant submissions based on CTD, eCTD, NeeS, eCopy, IMPD, VNeeS, DMF, ASMF, Clinical Trial Applications, and other submission formats. The Submission Management Hub applications are designed to maintain a comprehensive overview of your regulatory submission statuses across a number of products within multiple different geographic markets. Ensure effortless compliance by using the same validation and reviewing technology as 35 regulatory authorities worldwide, reduce errors, and increase productivity within your organization.
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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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Understand the complexities of the regulated pharmaceutical product journey, from drug development, to market launch and pharmacovigilance surveillance.
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