Government Relationship
60 years working with our clients in the registration of drug, cosmetics, food and medical advice.
It's not what we do, it's our results!
Values
We operate in the most diverse administrative, regulatory, legal, technical and governmental areas, fully advising our clients at all stages.
Our team will assist in planning, structuring, documentation and monitor the process until the application is approved by the competent bodies.
Prioritizing agile and close service to our customers allows us to have greater efficiency in the development of projects, making OATI a reference in the market.
OUR DIFFERENTIAL
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Headquartered in Rio de Janeiro, with branches in São Paulo and Brasilia, we have with a highly qualified and multidisciplinary team formed by paralegal professionals in health law, pharmacists specialized in Health Surveillance and professors and researchers (PhD) specialized in scientific literature (dossiers, medical rationales) and in clinical studies.
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Prioritizing agile service, efficiency in the development of the process and the close relationship with the customer, OATI has become a reference in the market, with deep specialized knowledge in the regulatory and legal areas.
With more than 50 years of experience, OATI – Organization of Technical Assistance to Industry works in the regulatory and legal consulting areas with the National Health Surveillance Agency (ANVISA) at the Ministry of Agriculture, Livestock and Supply (MAPA).
Commanded by the third generation of entrepreneurs, the company was one of the pioneers in this field. Over the years, it has followed the changes in the processes and legislation of regulatory affairs, such as the creation of the Sanitary Surveillance System (Law 6360 of 1976) and the decree regulating the law (Decree 79094 of 1977).
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In order to meet all the needs of our clients, we set up a legal structure and developed partnerships with large law firms to offer a complete solution.
Benefits of Regulatory Consulting
1
Greater Efficiency
We reduce the time and cost of the medication registration and regularization process at ANVISA
two
Conformity
We guarantee the compliance of medicines with ANVISA standards and regulations.
3
Specialization
Our team is made up of experts in health regulation and has extensive experience in the market.
