We are 100% Brazilian company with over one decade of experience in serving regulated industries (Pharmaceutical, food, cosmetics, health-care products, pharmochemical, and others).
We offer complete solutions for the management of regulatory affairs and pharmacovigilance in local and global scope. We can also be your extended team in several activities regarding quality system (validations, qualifications, training, audits, and others).
Quality and commitment in everything we do is our essence, what has been standing us out as one of the main partners of regulated industries.
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“The Organex team is very qualified and quick in fulfilling our company’s requests. We had the pleasure to work with them in a project and we were very pleased with the result, as well as with their conduct.”
“We could count on Organex partnership in several completed projects and some ongoing projects. I consider Organex a great partner to help us overcome daily challenges of such a critical sector as life sciences.
With high level of professionalism and punctuality, its professionals, who technically outstand in the market, engage in project development and the results have always been very good.
We will definitely consider Organex in future projects and we do not intend to put this partnership aside.”
“I followed several projects with Organex, in which both managers and analysts have great technical knowledge and commitment with business.
Surely these projects were great learning as well as an exchange of experiences, I am thankful to the company for all of the support, as usual.”
“In São Paulo, Criogênesis is the pioneer in the collection of stem cells from cord blood. We were audited by AABB (American Association of Blood Banks). It is an International Accreditation Program specific to Blood Banks that verified and approved, amongst other parameters, the validation documentation of “PREMIER” Computerized Systems, such program was exclusively developed by Criogênesis to support its operations. We appreciate Organex work and partnership, helping us since interactions and directions to prepare the documentation and system suitability as per CRF 21 part 11, the national regulation and in compliance with AABB, as well as in the preparation and execution of system validation paperwork.”
“We got pretty satisfied with Organex model. The team showed to be open to our needs and restrictions, concerned in adapting the tool as close as possible to our reality.
The professional assigned to work with us gave us all of the support and has always been very thoughtful, objective, and helpful throughout the process. Throughout the process, we had all expectations and deadlines aligned and the schedule was designed according to our internal routine.
Regarding the project and the product, so far, we are very satisfied with the result since Organex team made all efforts to meet the needs of food industry and has always proposed alternatives to make our work easier. Although we are still in phase of tool application and adaptation, we are satisfied with the project and we would indicate it to other industries.”
“Empresa de confiança, qualidade e parceira.”
“The team’s knowledge about systems validation, regulation, and other subjects made me very comfortable. The documentation template is well structured and complete, the expectations were met.”
“The experience with Organex team was very positive, we had support throughout the process, the deadlines have been met according to the schedule. I would have no problem in indicating Organex!”
The validation training on computerized systems met our expectations. I would like to thank for their attention and say we had an excellent experience!