In order to be fully functional in Brazil, companies that provide healthcare-related products must first receive approval and licensing of their enterprises and merchandise through the Brazilian Health Regulatory Agency (ANVISA), ensuring free commercialization of their products within this country.
The regulatory and consultation services offered by Stone Okamont include Product Regulation, Good Manufacturing and Distribution Practices Certification, Operating Permits (AFE), Local Health Surveillance Agency Operating Licenses, and Regulatory Audit Services.
Stone Okamont offers the advice needed to ensure that the bureaucratic process is simplified for our clients, allowing them to go through the entire regulatory process in a timely and objective manner, and promoting an uncomplicated understanding of this process for them.
Your enterprise may have international demands such as accompaniment of ANVISA inspection and audit; Holder Service (International Product Hosting); or standardization and preparation of international quality systems as prescribed by ANVISA. Stone Okamont performs any of these tasks just as you would, with the same objectives and transparency that enables you to easily understand the process, always bearing in mind the idea of ZERO BUREAUCRACY.
A Local Operating License is essential for your company to manufacture, distribute, store, transport and sell your products in a regulari...See More
We offer all the support required to obtain the Brazilian Health Regulatory Agency (ANVISA) permit, handling all the steps in the proces...See More
Stone Okamont prepares the technical process for registration, gathering the necessary product information from your company for presenta...See More
The Brazilian Health Regulatory Agency (ANVISA) requires a Good Manufacturing Practices Certificate for certain products because it is on...See More
This service is essential for foreign companies wishing to conform with The Brazilian Health Regulatory Agency (ANVISA), which is the wor...See More
The purpose of our audit is to perfect the quality system in an ongoing fashion, promoting the maintenance necessary to deliver benefits ...See More
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