DRUG PRODUCTS

Technical team of highly skilled pharmacists, specialists and masters in sanitary surveillance and extensive experience in the Drug Products field when dealing with the competent entities like the Ministry of Health (ANVISA).

When it comes to drug products, we provide regulatory and strategic support, carrying out activities such as:

Technical and strategic management at the competent entities;
Scientific literature and legislation research to verify product feasibility;
Clinical Studies (evaluation of safety and efficacy reports and submission of IMPD to Anvisa);
Drug registrations for rare diseases, which have specific legislation at ANVISA;
Registration and post registration of biological drugs;
Registration of Active Pharmaceutical Ingredients;
Price feasibility assessment and submission of price registration dossiers;
Technology transferring and product/service inclusion in the Ministry of Health programs;
Interpretation of legislation and strategic analysis;
Monitoring and drafting of advices on technical and administrative processes, health infractions, including import of products and customs clearance;
Assessment and guidance for the preparation of advertising material of products subjected 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;
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;
Quality Assurance, GMP and Due Diligence;
Appeals against rejections and compliance with requirements.

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 subjected 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 to 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.
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).