Inspired by the future creating the technology of today
Contact Us

BENEFITS:

Perform the regulatory affairs activity in a simple and expedite way, obtaining the following benefits:

DIGITAL ARCHIVES

Reduces the physical archive of your files by 80% using the Digital Archive component, reducing the storage costs of older archives, printed paper and physical searches

ALERTS

Displays alerts of product licenses that will expire in a pre-define timeline

REGIONALIZATION

Monitors regulatory affairs activities according to regions and /or locally

PROCESS

Makes the processing of regulatory affairs and its products an easy task in a integral way

MY PRODUCTS

Direct access to the actual state of the product, its past changes, and alerts with comments

REPORTS

Download your reports in Excel with filtered columns and with the company logo. Receive pre-defined reports by email every month

ASPECTS OF THE APPLICATION:

• The application is flexible; it adapts itself to changes suggested by the client and new modules to interact with other systems
• Backup the submissions and changes made to digital archives, meeting the requirements of internal audits
• The Administrator module allows limited access per user
• Controls the last changes made by date and name of user
• Adapts the content information, depending on the type of products that the business deals with
• The information in the software is based on the global requirement of the most important Regulatory Authorities such as the FDA and the EMEA, as well as other recognized regulatory agencies, allowing to develop highly successful process
• Database with encripted information