For quality system sectors
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Regulatory Affairs Management and Dossier Module (CTD)
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Who We Are

Brazilian company with international reach, present in more than nineteen countries, operating for almost two decades in regulated industries (Pharmaceutical, Cosmetic, Medical Devices, Medical Gases, Food, Cleaning Products, among others), with solid growth and recognized in the market for the quality of its products and services

Reference in Quality system service, especially in activities related to Validations (Systems, Cleaning, and Process), Qualifications (Equipment and Thermal), IT infrastructure Qualification, and Audits in Software and Service providers

Leader in solutions for Regulatory Affairs management with dossier module for compliance with the CTD standard

One of the leading companies in solutions for Post-Marketing monitoring (Pharmacovigilance, Toxicovigilance and Cosmetovigilance) with software in compliance with current standards, including the E2B standard

Our Solutions


RAS is our Regulatory Affairs solution, which offers complete management for the industry and can be accessed online from anywhere.


SIS is our Safety Information Solution. It allows you to record, assess and monitor the occurrence of adverse events related to the use of medication, cosmetics and healthcare products.

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Where we are

Since 2006, every choice of our team to care about quality, safety, integrity, and traceability has brought us closer to this achievement: we are in 22 countries.

We are in the Americas (North, Central, and South), the Middle East, and Europe. We are Brazilian, and our solutions meet global needs, we do not give up quality and are always seeking more technology and innovation. We are Organex!

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Our services

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