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ANVISA Audits for Foreign Companies

Auditoria Internacional ANVISA Auditoria Internacional ANVISA

RAGB provides foreign companies with advisory and consultancy services during audits, facilitating communication between ANVISA, the Brazilian Health Regulatory Agency, auditors, and the companies audited by them since we operate in the same territory and our staff speaks the same language of ANVISA auditors. Our company also ensures that quality systems of foreign companies meet the requirements of Brazilian governmental agencies.


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What Are Audits?

Audits are quality tools for use with domestic and foreign companies. They can be divided into several categories such as: internal or external; and simple, corrective, or preventive. Their relevance is linked to other measures, such as Good Manufacturing Practices (GMP).

Services We Offer

A highlight of RAGB’s foreign company services is the Enterprise Qualification Program, which is responsible for preparing professionals according to demands from governmental agencies.

We are qualified to develop pre-audit plans, give advice on nonconformity management, conduct employee training, and more, preparing companies to be internationally audited by ANVISA.

We monitor auditors from governmental agencies through every step of the international audit, supporting companies with actions and implementation, processes, and more.

Reconciling ANVISA with International Systems

RAGB also has the capacity to reconcile ANVISA with global quality systems. Our auditors will travel to your company and make sure that the existing system complies with Brazilian regulations. All this is done to facilitate the international audit without compromising the quality system deployed in the company, and avoid unexpected non-conformity detection.

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