ANVISA International Audits

Amaral & Cia Consulting offers the Regulatory Service of ANVISA International Audits Follow-Up that has the objective of simplifying and expediting the process of preparation of your company to receive the inspections of ANVISA auditors outside of Brazil.

We have a team that is eligible not only the settle the communication between your company and ANVISA but also to assist you with meeting the requirements and corrective actions of non-compliances found in previous audits, as well as following-up the inspection agency auditors, assisting your company with certifications you might need.

The RDCs – Anvisa Board of Directors Resolutions – regulate the good practice of manufacturing and distributing, and they have different emphasis and standards from the rest of the globe. In its majority, the professionals responsible for the foreign companies quality department are not qualified according to such standards. A spotlight factor in our services is the Program of Teams Training and Qualification, capacitating professionals all around the world based on the Brazilian resolutions (RDCs). With wide experience in international audits, Amaral & Cia makes viable an effective communication between ANVISA auditors and the company audited.

Our professional is capable of making the GMP Certification viable, increasing substantially the chances of audit approval, because experience and practice led the team to tools that will shorten the ways, whichever the language and culture of the country where the process will be held might be.

Amaral & Cia Consulting prepares professionals for a mechanism called front room/back room, which consists of guaranteeing that in every process specialists are available whenever more specific clarifications are needed, and it also guarantees greater celerity in the on-going and result of the audit.

We aim to be your best solution for your ANVISA International Certification.

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