Information Management to Achieve Effortless Compliance

EXTEDO combines regulatory expertise with innovative technology to support  navigating complex compliance requirements. Through close collaboration with regulatory agencies and industry leaders, EXTEDO actively contributes to the development of global and regional regulatory standards.

By providing a suite of registration, submission, document, quality and safety management solutions called EXTEDOpulse, EXTEDO automates and accelerates business processes and secures Effortless Compliance during every step of pharmaceutical product development. EXTEDOpulse enables structured data handling, process automation, and seamless agency communication while supporting regulatory standards such as IDMP, eCTD, and E2B(R3).

Ensuring seamless submission compliance with global requirements

Supporting all common standards like NeeS, eCTD, eCTD 4.0, eCopy, IMPD, PIP, VNeeS, DMF, ASMF, Clinical Trial Applications, and other regional formats, it streamlines submission processes throughout the entire lifecycle. From submission compilation, validation, reviewing and viewing to agency assessment and decision-making, each step is managed efficiently throughout the entire process.

Your team benefits from increased productivity as review, approval and delivery times to market significantly decrease while errors are reduced thanks to advanced automation. 

Optimizing regulatory activity management and ensuring IDMP and XEVMPD compliance

Benefit from a real-time overview of the state of your regulatory activities in the EXTEDOpulse Registration Management Hub powered by CARA.

The EXTEDOpulse Registration Management Hub powered by CARA centralizes registration data, tracks global submissions, and provides a structured, real-time overview of regulatory activities. Variations, renewals, and approvals are managed seamlessly ensuring full transparency across teams and stakeholders. An integrated gateway to regulatory agencies enables timely updates and alignment with evolving requirements.

By increasing efficiency and reducing complexity, regulatory planning is optimized for greater control and compliance.

Driving operational excellence with a powerful Quality Management Solution (QMS) tailored for the life sciences industry

The EXTEDOpulse Quality Management Hub powered by CARA facilitates regulatory alignment to keep you in control.

With EXTEDO’s Quality Management Hub powered by CARA, organizations can centralize all quality processes, ensure consistency, and maintain full regulatory alignment. The powerful QMS streamlines document control, automates workflows, and facilitates the management key quality processes such as audits, CAPAs, change control, complaints, and training.

With real-time tracking and seamless integration, it enhances efficiency, minimizes risks, and supports maintaining the highest quality standards. 

Streamlining comprehensive and timely processing of every safety case in an advanced multivigilance solution supported by AI

The EXTEDOpulse Safety Management Hub ensures that details are watched and deadlines are met.

By streamlining case creation, analysis and reporting with AI-driven functionalities across medicinal products, medical devices, cosmetics, and nutraceuticals, the Safety Management Hub reduces manual workload and enhances efficiency. It supports E2B(R3) and MedDRA coding standards as well as IDMP compliance, facilitating the generation of PSUR, PBRER, PADER, and DSUR documentation.

Its direct link to the regulatory authorities through certified gateways makes manual submission obsolete, ensuring timely and compliant safety reporting.

Empowering Agencies with Streamlined Regulatory Processes and Centralized Compliance

EXTEDOpulse for agencies centralizes the management of regulatory submissions, allowing pharmaceutical companies to upload submissions, request extensions or variations, and receive status updates through a single communication channel. Automated workflows reduce review times and errors, while data from various sources is integrated for full transparency.

Precise content comparison, validation, and tracking of changes are made easier, and centralized document storage ensures quick access to the current versions. Built-in validation guarantees data accuracy, simplifying the management of marketing authorizations and enhancing overall regulatory compliance and efficiency.