We are focused on your company and your products
We are the most traditional office specialized in Regulatory Affairs and ANVISA in Brazil.
Founded by Dr. Marília Sponza more than 50 years ago, we advise the main Brazilian and International companies in the area of cosmetics and sanitizing.
We are a multidisciplinary technical team, with full expertise not only on the technical aspects, but also on all legal areas, especially in health law.
Our goal is to facilitate all the procedures and permits necessary for your company before ANVISA and MAPA.
EXPERTISE
Our office advises the whole industry of cosmetics, sanitizing, food, health products and OTC medicines.
We assist manufacturers, importers, distributors and retailers since the beginning of their operation by obtaining the necessary licenses and authorizations for the company until compliance with all the standards and requirements of ANVISA and MAPA for the products.
We are a team of highly specialized with multidisciplinary professionals with experience in Sanitary Surveillance, ANVISA, Foreign Trade, regulatory and tax law.
Consult our team and see how we can help your company better understand technical concepts.
MISSION:To be a full service office in health law.
EYESIGHT: To be a world reference in sanitary technical consultancy
VALUES:
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Ethics
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Transparency
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Honesty
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Respect
Record
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We provide consulting services, technical assistance and follow-up of processes from formulation to full approval of products by ANVISA, State and Municipal Sanitary Surveillance and Class Councils.
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Consultancy and complete Technical Assistance for the Regularization of Companies and Products, including all the guidance for the adjustments necessary to comply with Good Practices in accordance with the health requirements set forth in the Legislation and Regulations.
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Training your team in Good Practices.
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Audits to verify compliance with the requirements of good practices in the corresponding product class.
Class council
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Registration of Company and Assumption and Change of Technical Responsibility in the corresponding class council.
Health Surveillance (State and Municipal)
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Initial License, License Changes and Revalidation.
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defenses
National Health Surveillance Agency - ANVISA
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Company Registration at ANVISA
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Alteration, updating of the registration and size of the company
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Operating Authorization (AFE) and Special Operating Authorization (AE); Initial Authorizations and Changes for all activities.
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Records, Notifications and Registration of Products: Medical Materials and Equipment (Health Products - Related), Food, Cosmetics and Sanitizing
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Alteration, Inclusion and revalidation of Registration.
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Certification of Good Manufacturing Practices, Storage and Distribution of Products under Sanitary Control by ANVISA.
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Consultancy and Assistance specialized in Import and Export of products subject to ANVISA approval, including the request for quotas and Import/Export Authorization for Products under special control.