Services for operations in Brazil.

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Regulatory support for companies entering, operating or expanding in Brazil. Clear scope, technical assessment and direct contact with Tecnovisa.

TECNOVISA · ANVISA

Anvisa product regulatory services

Plan the regulatory pathway, technical documentation and responsibilities for products entering the Brazilian market.

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TECNOVISA · ANVISA

Regulatory consulting for medicines and pharmaceutical ingredients

Assessment of pharmaceutical projects, documentation and regulatory maintenance, with a scope tailored to the product category.

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TECNOVISA · ANVISA

Anvisa operating authorization — AFE

Align company authorizations with the products, activities and establishments involved in your Brazilian operation.

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TECNOVISA · ANVISA

Anvisa AFE for medical device companies

Consulting for manufacturers, importers, distributors, warehouses and carriers of medical devices, according to the applicable requirements.

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TECNOVISA · ANVISA

Anvisa AFE for pharmaceutical companies

Plan company authorization for medicines and pharmaceutical ingredients, considering activities, facilities and any special-control requirements.

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TECNOVISA · ANVISA

Anvisa AFE for cosmetics companies

Regulatory support for cosmetics, personal hygiene products and perfumes, based on the activities the company actually performs.

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TECNOVISA · ANVISA

Anvisa AFE for cleaning and disinfectant product companies

Company authorization for regulated cleaning and disinfectant products, considering the category, business activity and operating structure.

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TECNOVISA · ANVISA

Special Authorization — AE

Assess additional authorizations for activities involving substances or products subject to special control in Brazil.

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TECNOVISA · ANVISA

Changes and extensions to Anvisa AFE

Evaluate the regulatory impact of a new address, changes to company information or expansion of authorized activities.

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TECNOVISA · ANVISA

Medical device registration and notification

Support for medical device market access in Brazil, based on intended use, classification and technical documentation.

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TECNOVISA · ANVISA

Cosmetics regulatory services in Brazil

Assess product classification, labeling and the applicable regulatory pathway for cosmetics, personal hygiene products and perfumes.

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TECNOVISA · ANVISA

Cleaning and disinfectant product regulatory services

Assess intended use, presentation and the appropriate regulatory pathway for products subject to Anvisa requirements.

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TECNOVISA · ANVISA

Food and dietary supplement regulatory services

Classification, labeling and regulatory planning for food and dietary supplements intended for the Brazilian market.

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TECNOVISA · ANVISA

Local sanitary licensing

Plan establishment licensing with attention to local requirements, business activities and responsibilities.

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TECNOVISA · ANVISA

Quality, good practices and inspection readiness

Align documentation and operating routines and assess the work needed for compliance and certification projects.

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TECNOVISA · ANVISA

Support for Anvisa technical requests

Review the official request, the process history and the available evidence to define a consistent response strategy.

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TECNOVISA · ANVISA

Brazilian registration hosting service

Evaluate registration hosting with clear responsibilities for the manufacturer, registration holder and commercial operation in Brazil.

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TECNOVISA · ANVISA

Ongoing regulatory consulting

Organize recurring regulatory needs, portfolio changes and ongoing obligations through a clearly defined service agreement.

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TECNOVISA · ANVISA

Regulatory assessment for company acquisitions

Assess available business opportunities and whether their documentation and authorizations fit your intended operation.

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TECNOVISA · ANVISA

Regulatory support for importers

Assess regulatory feasibility and company responsibilities before the first import or an expansion of the product portfolio.

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TECNOVISA · ANVISA

Regulatory support for distributors

Plan authorizations and documentation for distribution and wholesale activities involving regulated products.

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TECNOVISA · ANVISA

Regulatory support for carriers and warehouses

Assess sanitary requirements for logistics, storage and transport, considering product categories and contractual responsibilities.

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TECNOVISA

What is the next step for your operation?

Discuss your company’s regulatory needs and the scope of a suitable engagement.

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Request a proposal on WhatsApp ↗