Julho 11, 2018




All around Pharma

From R&D to Regulatory Affairs or Pharmacovigilance

The core of your information


Your data management software for the Pharmaceutical Industry

A complete

Quickly navigate through our system and have 360º perception of the entire product history and projects

Improved team

Manage projects and people in a simple and swift way, improving your team coordination


Access a KPI and report dashboard that helps make data-driven business decisions

All data
in one place

Centralize all data, understand process bottlenecks and reduce the loss of information and risk of non-compliance and audit failure

Our mission

Help your company deliver the qualitative and quantitative information necessary to be compliant and efficient, enabling you to be focused on your core business


4 different Modules, all the information

4 Modules that will cover all your Technical Activities

Manage data, projects, project owners, milestones and KPIs in a single platform, making conscious and informed business decisions focused on efficiency and increased compliance.
  • Keep project Stakeholders clearly identified;
  • Set and Analyse customized product development milestones
  • Link relevant R&D Documentation
  • Tracking of decisions and discussion on ongoing projects
  • Track supporting information on clinical studies details
  • Detailed project reporting including a timeline overview
  • Easily relate product development batches with stability studies information
  • Comprehensive and secure audit trial capturing
Our platform will help you through all types of Regulatory Procedures guarantying compliance and a much easier management
  • Automated features to populate relevant product data
  • EMA standard reference framework Substance, Product, Organisation and Referential (SPOR) master data support
  • Manage your Product Information. (SmPC, PIL and Labelling)
  • Easily start and manage regulatory activities (new MA, variations or submissions) through a project management tool
  • Keep track of regulatory timelines
  • Predefined templates with project steps for Regulatory Activities
  • Track submission activities and progress
  • Resource management: who is working on what?
Be able to perform all the pharmacovigilance activities related to Safety and manage all the applicable data in a single, shared, updated and communicative platform
  • Electronic communication with EMA E2B gateway
  • Adverse events management database
  • Management of PSUR and RMP
  • Signal detection
  • Management of Literature Screening
  • Compliant with relevant drug safety regulations and regulatory guidelines
  • Import/export of XML data
Manage all Quality Procedures and Processes that interfere with your products lifecycle, from Product Studies to Supplier Management. A unique vision on Quality, a simpler way to be compliant.
  • Stability Studies – Plan, Execute and Report Results
  • Supplier Management – From Initial Qualification to continuous evaluation
  • Change Control Management – A tool used by all departments, centralized on the product
  • Document Management System
  • Human Resources Management System – Training Control and Staff Management
  • Audit Planning