Pharmaceutical Area

Technical team of highly experienced pharmacists, specialists and masters in sanitary surveillance.

Acting in the Regularization of Companies and Products with the competent bodies of the Ministry of Health (ANVISA):

Medicine;
Biologicals;
Health products;
Inputs;
Cosmetics;
Sanitizers;
Smoking product;
Certification of Good Manufacturing Practices;
National and International Audits.

We provide regulatory and strategic support, carrying out activities such as

Technical and strategic management with the competent bodies;
Research in legislation and scientific literature to verify product feasibility;
Clinical studies (assessment of efficacy and safety reports and submission of IMPD to ANVISA);
Registration of drugs for rare diseases, which have specific legislation at ANVISA;
Registration of Active Pharmaceutical Inputs;
Price feasibility assessment and submission of price registration dossiers;
Technology Transfer and inclusion of products/services in Ministry of Health programs;
Interpretation of legislation and strategic analysis;
Monitoring and drafting of opinions on technical and administrative procedures, health infractions, including importation of products and customs clearance;
Assessment and guidance for the preparation of advertising material for products subject to sanitary control, including labels, websites, folders, magazines, among others;
Clarifications and updating of technical standards and official press publications;
Audits in Good Manufacturing Practices, Quality Control;
Validation Process Assessment and Stability Studies;
Esclarecimentos e atualização das normas técnicas e publicações oficiais da imprensa oficial;
Assessment and indication of efficacy and safety studies for new products, including identification of researchers and research institutions;
Participation in discussions at ANVISA and in Public Consultations;
Registration of smoking products.
Quality Assurance, GMP and Due Diligence

Company Regularization and Due Diligence

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).