EXTEDOpulse - A Comprehensive RIM Software Solution for Life Sciences

Everything you need to tackle the planning & tracking, document, registration, submission and safety management challenges of today.

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.

EXTEDOpulse has been designed with these aspects in mind to help you connecting the dots throughout the entire lifecycle of pharmaceutical products.

EXTEDOpulse is a comprehensive RIM software solution consisting of five hubs that address every step of pharmaceutical product development. Use the applications individu­ally with your existing IT infrastructure or gain additional value by using them together based on your requirements and demands. With EXTEDOpulse, the flexibility for better solutions is in your hands.

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.

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.

Benefits

Connected systems work with one another for maximum productivity, efficiency and simplicity.

Use the different EXTEDOpulse apps individually within your existing IT infrastructure or gain additional value by using them together in the cloud.

All hubs of EXTEDOpulse combine to a complete Regulatory Information Management System (RIMS).

EXTEDOpulse includes an even bigger customer focus and customer proven solutions thanks to the EXTEDO influencer program.

Planning & Tracking Hub

The EXTEDOpulse Planning & Tracking hub helps you achieve results faster than ever. Efficiently plan and track the regulatory activities, processes, submissions and commitments related to your entire portfolio of products. Real-time reports, analytic dashboards, automated workflows, project management tools and publishing features all combine to give you a complete overview of your project performance across your organization.

Document Management Hub

The EXTEDOpulse Document Management hub supports you in managing regulatory data and documents throughout the entire submission lifecycle, connect stakeholders with automated processes, eliminate the need to conduct on-site monitoring visits, manage SOP and related training documents, manage 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.

Submission Management Hub

Efficiently build, view, validate, publish, and review compliant submissions based on CTD, eCTD, NeeS, eCopy, IMPD, CTA, VNeeS, DMF, ASMF and other submission formats. The submission management 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.

Safety Management Hub

The Safety Management Hub enables you to minimize costs and deliver best-practice monitoring and reporting workflows crucial to your business success. Create, review, submit and maintain pharmacovigilance 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.

Services

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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