RAGB specializes in the Brazilian Good Manufacturing Practices (GMP) Certification. We guide companies through the ANVISA licensing process quickly and ease the process through bureaucracy layers.
The Good Manufacturing Practices program, which is used worldwide, is one of the most comprehensive programs of its kind. It simplifies product commercialization in a number of South American and European countries. In Brazil, ANVISA demands that companies aiming to sell their products in Brazil to have GMP Certificates for certain products.
According to the Brazilian regulation RDC 185, every Class III or IV product subject to ANVISA regulation, as well as some Class II products, must have a GMP certificate.
RAGB’s team is qualified to plan pre-audits and provide in-depth training related to quality system deployment and standardization. We can also help companies obtain GMP certification, in conformity with ANVISA requirements.
We monitor the auditing processes of Brazilian governmental agencies, supporting companies throughout every step of the required procedures. We are able to come up with tailored solutions for each client, increasing the effectiveness of our actions.
Many companies have already implemented quality systems, but may have to reconcile them with ANVISA’s demands. We perform this quality system standardization, pointing out possible improvements and nonconformities. At the same time, we help your company develop a course of action for obtaining Good Manufacturing Practices Certification in conformity the requirements of governmental agencies.
Certain companies are only required to implement quality systems, and are not required to get GMP Certification. In these cases, RAGB provides advice about this process. We carry out preliminary diagnosis, qualify employees, and apply other procedures that promote sustainable system implementation and maintenance.
The RAGB has a teamwork with specialists in regulatory affairs with ANVISA including Local Operat...See more
RAGB provides foreign companies with advisory and consultancy services during audits, facilitatin...See more
RAGB performs your company in Brasil. We offer all services related to company and products regul...See more