RAS
SIMPLE, SAFE AND EFFECTIVE

What is
RAS4?

RAS is our ​​Regulatory Affairs software, a leader in the Brazilian market, operating in 21 countries and 3 continents. It offers complete management for the industry and can be accessed online at any location.

The software has a dossier module in order to meet all the demands of the sector, in addition to the management of regulatory information and KPIs. Therefore, managers can obtain real-time KPIs and alerts to mitigate the regulatory risk of missing important deadlines such as submission of renewals.

Complete Solution

Easy Deployment

Intuitive
Use

Excellent cost-benefit

Browse the

RAS

Discover the

Dossier Module

RAS4

Regulatory Affairs Management

Our customers have a rich set of tools and features, with easy access to information and simplified search. The flexibility of the system also stands out: it is possible to create new fields, without making updates or carrying out customization projects.

Main Features

• Dashboards configuration;
• Submission of deadline alerts for renewal of registers/certificates, submission, and fulfillment of deficient letter;
• Storage of Regulatory Affairs registers/certificates, products, presentations, submissions, partners, and documents;
• Organization of regulatory documentation through folders that can be linked to your register/certificates or submission;

• Planning of submission demands and ongoing or planned activities for the team;
• Management of own and third-party factories, including authorizations and certifications;
• Lists setting and new fields in just a few minutes;
• Log and audit of all activities performed, enabling tracking of all details of solution usage and data change history.

You will have a flexible and configurable system that adheres to the needs of the business, which enables you to create and change new fields in a few minutes.

Intuitive Use

See what you can manage with real-time updated dashboards:

RAS4

Dossier Module

The dossier module is the right tool to automate the process of organizing, managing, and controlling the dossiers. By using it, you can register structures in folders to meet the CTD standard.

See the main benefits of the RAS Dossier Module:

• Organization and management of dossiers in CTD and technical dossiers;
• Manage folders in different formats, in a single system;
• Checking the size and extension of the files;
• Dossier documents check;
• Tool in Portuguese and easy access to support;
• Unlimited number of access profiles.

All actions performed are recorded in an audit trail

Organex and Extedo

Partnership designed to provide a complete solution for eCTD. See the supplementary functions of eCTD manager regarding the dossier module:

• Meets all submission requirements in eCTD format;
• Enables you to make submissions to countries that use the eCTD format (EU, US FDA, AU, CA, CH, GCC/KSA, JP, TH, ZA), as well as the IMPD, CTA and NeeS formats;
• Structure in eCTD modules folders;
• Document life cycle management;
• Document and dossier versioning;
• Creating links and bookmarks in documents;
• Integration with DMS systems, including, such as SharePoint, open text, and others.

Meet SIS,

our solution in Reporting and Pharmacovigilance Management