License and Permit to Operate (AFE)
Every company that intends to extract, produce, manufacture, transform, synthesize, purify, fraction, pack, repack, import, export, store or dispatch (distribute and commercialize) products subject to sanitary control must be regularized with the competent sanitary agencies (State/Municipal Sanitary Surveillance - Sanitary License and, when pertinent, ANVISA - in the Federal scope - Operation Authorization).
Only after obtaining the Operating Permit and Sanitary License will the company be able to submit the processes of regularization of products with ANVISA.
Visanco advises your company to obtain the licenses and sanitary authorizations starting from the assessment of the ground plan/layout, technical visits to the facilities to check the structural conditions and necessary adjustments, guidelines to prepare the manuals and POP's, as well as the preparation of the processes (petitions) for the due consent of ANVISA.
Prior Audits for Good Manufacturing Practices (GMP), Storage and Distribution (GMP) and Control Certifications
We perform previous audits in the industrial units, in Brazil or abroad, with the objective of bringing to the quality team the understandings and clarifications regarding the Brazilian GMP regulations, as well as evaluating all the structure and document composition (POP's, protocols, validation reports, etc.), physical areas, flows, auxiliary systems and everything related to the GMP Certification process.
From these activities, corrective actions and action plans are discussed with the client for the proper and full compliance with the quality requirements required by ANVISA.ealizamos auditorias prévias nas unidades fabris,no Brasil ou no exterior, com o objetivo de levar à equipe da qualidade os entendimentos e esclarecimentos frente a regulamentação brasileira de BPF, bem como avaliamos toda estrutura e composição documental (POP’s, protocolos,relatórios de validação e etc.), áreas físicas, fluxos, sistemas auxiliares e tudo aquilo que estiver vinculado ao processo de Certificação de BPF. A partir dessas atividades, ações corretivas e planos de ação são discutidos com o cliente para o devido e integral cumprimento aos requisitos de qualidade exigidos pela ANVISA.
Regulatory Due Diligence
In processes of acquisition, merger, incorporation or spin-off of companies, due diligence actions are often required. These are nothing more than investigative processes for assessing the risks in business opportunities.
Thus, we perform on-site verification of the physical structure and documentation provided by the client regarding the regularization of the company (License and AFE), as well as the regularity of the products (valid registrations, updates via post-registration, certification of manufacturers, among others).