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Consultancy

For quality system sectors

RAS

Regulatory Affairs Management and Dossier Module (CTD)

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

RAS4

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

SIS

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.

Learn more about Organex

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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Customers

Testimonials

"We were very pleased with the Organex model. The team has always been open to our needs and constraints, concerned about adapting the tool to our reality. The professional who assisted us and provided all the support was always very careful, objective and helpful throughout the entire process. Throughout the process we had all expectations and deadlines aligned and flexible schedule according to our internal routine. Regarding the project and product, we are very satisfied with the result so far, because Organex's team has made everything possible to meet the needs of the food industry and has always proposed alternatives to facilitate our job. Although we are still in the phase of implementation and adaptation of the tool, we are satisfied with the project and would recommend it to other industries."

"I have followed several projects from Organex in which both managers and analysts have shown great technical knowledge and commitment to the business. These projects have surely been of great learning and exchange of experiences. I would like to thank the company for the constant support."

"Criogênesis is a pioneer in the collection of stem cells from cord blood in São Paulo. We were audited by the AABB (American Association of Blood Banks). AABB is an International Accreditation Program specific for Blood Banks, which have verified and approved, among other parameters, the documentation of the "PREMIER" Computerized Systems Validation, a program developed exclusively by Criogênesis to support its operations. We appreciate the work and partnership of Organex which helped us from interactions and guidelines for the elaboration of the documents and the system's compliance with CFR 21 part 11, national standards and the AABB and the elaboration and execution of the system validation documents."

"I am extremely grateful for the work done by the entire Organex team. The project management, documentation, and face-to-face meetings were of great value and learning for the entire Hipolabor team. The documentation for validation was already presented for sanitary inspection and was praised not only for the organization of information but also for the quality of work and compliance with standards. New projects are coming!"

"There have been several projects already completed and some still in progress in which we could count on the partnership with Organex. I consider Organex a great partner to help us overcome the daily challenges of such a critical industry as the life sciences. With great professionalism and punctuality, its professionals, technically top-notch in the market, commit themselves to the development of the project and the results have always been very good. We are absolutely sure we will consider Organex for future projects and do not intend to leave this partnership aside."

Our services

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