EXTEDOpulse is a complete, modular Regulatory Information Management System (RIMS) designed to help life sciences organizations, including small CROs, large pharmaceutical companies, and regulatory agencies, achieve "Effortless Compliance™."
The platform addresses the entire pharmaceutical product lifecycle, from drug development through market launch and pharmacovigilance surveillance.
Key Features and Capabilities:
EXTEDOpulse is built around five major, interconnected hubs, often utilizing the Generis CARA™ foundational platform for content and business process management:
- Submission Management Hub: Enables the compiling, viewing, validating, and publishing of compliant submissions (eCTD v3/v4, NeeS, eCopy, IMPD, VNeeS, DMF, ASMF, Clinical Trial Applications, etc.). It uses the same validation engine trusted by over 35 regulatory authorities worldwide, including the EMA, significantly improving quality and consistency.
- Registration Management Hub: Centralizes registration data and tracks global submissions. It provides a single source of truth for medicinal product information, supporting IDMP and XEVMPD data standards.
- Safety Management Hub: A Multivigilance Management Solution supporting E2B R2/R3 data standards, streamlining case creation, analysis, and reporting with AI-driven functionalities for medicinal products, medical devices, cosmetics, and nutraceuticals.
- Quality Management Hub: Provides end-to-end control over quality processes, including automated CAPA workflows, deviation documentation/tracking, change control coordination, and document control.
- Document Management Hub: A content management solution that supports regulatory, clinical, quality, and SOP documentation, enabling collaboration and electronic signatures. [cite: 8, 12, search 3]
The system is highly configurable and can be used to fully integrate with existing IT infrastructure, offering flexibility to select individual applications or a complete end-to-end solution.