A Proven Solution for EVMPD Compliant Submissions
Volume 9A is the guidance documentation for marketed medicinal products for human use in the European Union. It brings together general guidance on the requirements, procedures, roles and activities in this field, for both Marketing Authorization Holders and Competent Authorities of medicinal products for human use and veterinary medicinal products. Volume 9A also incorporates international agreements reached within the framework of the International Conference on Harmonisation (ICH).
Aris Global® is the recognized leader in the implementation of the E2B standard for electronic communication of safety case data. Across the globe, more than 55 customers, including major regulatory agencies, rely on agXchange RSM (Regulatory Submission Module) for electronically exchanging safety data such as ICSRs, SUSARs, attachments and periodic reports.
agXchange RSM supports the submission of the EVMPD product data as requested by the EMA, which can be easily extended to support the electronic submission of other regulatory data including SPL, PIM and eCTD documents.
As with all Aris Global products, agXchange RSM is available as an on premise as well as an on demand solution on the agOnDemand platform. For over four years, agOnDemand has been providing best-in-class Software-as-a-Service (SaaS) to life science companies to help them meet their regulatory requirements without the pressure of maintaining sophisticated IT infrastructures.
A Proven Solution for EVMPD Complaint Submissions
agXchange RSM manages and traces all electronic distribution of regulatory safety submissions and receipts in order to meet complex and often differing regulatory requirements. The application also supports the submission of differing content dependent on the receiver meting local reporting obligations. Other key features include:
Automated submission of EVMPD product data
Provides encryption and decryption of documents using sophisticated standard protocols such as AS1 and AS2
Comprehensively tracks every transaction including submission dates and acknowledgements
Provides complete audit trail of all gateway activities
Generates highly secure regulatory document exchange platform
Integrated with any other regulatory information management system easily via a standards-based integration process
Provides extensible architecture that can support any future submission standards
Has flexible mapping and configuration to allow for the electronic exchange of files in a custom format
Can be fully integrated with the Register™ system, but is database independent and can operate seamlessly with any other regulatory information management system
agXchange RSM leverages the proven E2B data exchange system from Aris Global, (agXchange ESM) to provide a backbone for the electronic exchange of all regulatory data between internal and external stakeholders. The agXchange electronic exchange platform supports the encryption and decryption of documents, using standard protocols such as AS1 and AS2.
Automated submission of EVMPD increases submission efficiency and avoids costly errors associated with the manual submission process
Support for sophisticated encryption and decryption ensures a highly secure document exchange platform and eliminates risk while exchanging sensitive documents with internal or external stakeholders
Detailed tracking of all activities and events such as acknowledgements ensures accelerated resolutions and regulatory approvals
Standards based technology ensures easy integration with any regulatory system enabling end to end automation and improved returns
Easily extensible architecture provides insurance against disruption from changes to submission standards in future