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Regularization of Companies

For a Brazilian company to be able to manufacture and / or import health-related products and thus commercialize in the national territory, it is mandatory to regularize the company following the rules and requirements of Brazilian regulatory bodies.

Kenko specializes in regularization and full monitoring for:

Layout assessment and documentation support
Obtaining AFE (Authorization for the Operation of a Company)
Change of RT, RL, address and corporate name
Company size update
Assembly and process protocol

Certificate of Good Manufacturing Practice

The GMP Certificate is mandatory for national and international companies of medicines and health products that need to market their products in Brazilian territory. We are a family owned and operated business.

Pre Inspection

Evaluation of the Quality System, Installation and Manufacturing Processes
Guidance for adequacy of identified non-conformities

Implementation of the Quality System documentation

In the case of companies that need to implement the Quality System

Inspection follow-up with Anvisa

Provide the necessary support during the inspection to facilitate communication between inspector and auditee.
Guide the company towards compliance with non-conformities.