Experts in compliance services and solutions for health-care and well-being industry

ORGANEX was established in 2006, in a small incubator room at USP (University of São Paulo), in the city of São Paulo, where the project of our 1 st software started.

In 2007, we moved to the neighborhood of Vila Nova Conceição, in São Paulo, where we remain to date. In the same year, the first version of the system was launched for regulatory affairs area of pharmaceutical industries, RAS, and the product was first sold.

The success of our partnership with regulated industries paved the way for the development of SIS in 2008, a system designed for serving pharmacovigilance demands, which has consolidated us as the main supplier of solutions for these areas in Brazil.

The publication of RDC dated April 17, 2010 gave rise to the need to adjust our Software to fulfill the computerized system validation regulations. This was when we started the adjustments and preparations of the first validation documents in our software and, in 2011, we extended this service to our clients for ERPs, WMS, LIMS, GED, Automation systems validations and others. Everything with the purpose to take our quality and safety pattern to regulated industries.

In 2012, we started a new work model with the main purpose of serving the various areas of quality system, such as Control and Quality Assurance, Cleaning Validations, computerized process and systems, Equipment qualification, among others.

In 2014, aiming at improving communication with our partners and the representation of our evolution and maturity before the market, we underwent the development process of a new visual identity.

In 2018, we first implemented Organex technology in food industry.
In addition, we had the launching of a new product for ctd, TDS. For assistance of pharmaceutical industries within the phase of adjustment to digital format (Nees).


To conduct health-care and well-being companies in achieving excellence in quality and safety for regulatory and compliance processes.


Be the reference of quality in health-care and well-being sector through our products and services.


Honest and clear in our internal and external relationships;
Committed with quality, safety, and deadlines;
Appreciation and respect for our employees; In love with health.

Organex offers full package of services to assure success in software implementation.

Learn more about our services! Services


Subscribe to receive exclusive news from Organex and the market.