Leading the Way with Comprehensive Regulatory Affairs Information Management System
Aris Global understands that Regulatory Affairs departments face significant challenges to stay ahead of the ever-changing regulatory landscape. Our Total Regulatory suite of regulatory information management (RIMS) and compliance management software, integrates compliance with business processes over the entire product management lifecycle and product data submission management.
With every drug and medical device recall, life science companies are becoming painfully aware of the increasing information gaps between regulatory affairs and other parts of the company. Total Regulatory solutions bridge those gaps with powerful, market-proven solutions that are compliant with regulations of the US FDA, and European Medicines Agency (EMA).
Used by the world's leading pharmaceutical companies, Total Regultory compliance solutions provide the assurance that regulatory affairs is successfully managing and tracking all registrations, re-registrations, updates, EVMPD submissions, eCTD related documents, questions/commitments and change requests in a consistent and compliance manner.
The market-leading regulatory and compliance solution for centrally managing and tracking global product registrations a product's entire lifecycle.
This market-leading regulatory submissions application enables efficient submission of medicinal product dictionary related data as required by the EMA under the new EVMPD regulation. It can be easily extended to support the electronic submission of other regulatory data including SPL, PIM and eCTD documents.
i4i is an XML-based SPL (Structured Product Labeling) solution that addresses all authoring and lifecycle management of e-label production.
In today's global market, Total Regulatory helps life science companies aggressively seek to mitigate risk, lower their research and development costs, and secure their manufacturing and product supply chains.
- Manages entire global product registration and tracking process
- Accelerates product approvals and reduces time to market
- Mitigates risk by providing a single authoritative source of approved product information
- Provides end-to-end support to EVMPD submissions including preparation of structured substance information (SSI) preparation, validations and XML-based submission file generation
- Provides intelligent decision support through comprehensive reporting and notification and management of documents that help prepare eCTD and product dossier submissions
- Enables manufacturing compliance by providing access to approved product information
- Ensures consistent planning and submissions through use of planning templates
- Provides end-to-end submission tracking and management for products, formulations, and packages in every market linking all supporting documents to a product, regardless of location
- Manages registration with in-license and out-license partners
- Automates submission, increases efficiency of EVMPD submission
- Reduces costly errors associated with manual submission process
- Supports sophisticated encryption and decryption ensuring secure document exchange
- Tracks all events and activities related to active pharmaceutical ingredient (API) maintenance and approvals maintenance processes
- Integrates with any regulatory information management system enabling end-to-end automation and quick ROI
- Easily extends and adapts to changes in standards and future regulations
- Leverages E2B data exchange system, (agXchange ESM) providing secure backbone for electronic exchange of all regulatory data between internal and external stakeholders
- Encryption/decryption using sophisticated standard protocols such as AS1 and AS2Comprehensive tracking of all transactions, submission dates and acknowledgements
- Comprehensive tracking of all transactions, submission dates and acknowledgements
- Complete audit trail of all gateway activities
- Extensible architecture to support incorporation of future submission standards at the global and/or local level
- Delivers a comprehensive XML-based solution for product labeling