| |
Fields of action of Visanco in Sanitary Surveillance and Inspection:
Its fields of action in other activities are:
Fields of action of VISANCO in Sanitary Surveillance and Inspection:
Registration of Products |
 |
Elaboration and follow up of processes of registration of products in the Ministry of Health Sanitary Surveillance Department (ANVISA/MS) and in the Ministry of Agriculture (MAPA). The products are: drugs, industrialized food, food products of animal and vegetable origins, juices and drinks, medical devices, cosmetics and hygiene products, sanitizing products and tobacco.
Operating License |
|
Elaboration and follow up of processes to obtain the operating license to produce, distribute, import, export, packaging, re-packaging, and commercialize drugs, medical devices, cosmetic and hygiene products, sanitizing products, and food products. It also includes the application of previous sanitary inspection checklist.
Import and Export |
|
Preparation and speed up of processes for the acquisition, along with the competent official entities, of importing and exporting licenses, exporting authorization certificate, psychotropics and narcotic substances importing quota, and an importing guide acquiescence for health products and equipments.
Sanitary Infractions |
|
Advisement to solve problems of companies, along with the Sanitary Surveillance System, concerning the non-conformities of establishments, products, advertisement and other kinds of sanitary infractions.
Good Manufacturing Practices and Quality Control (GMPQC) |
|
Process elaboration and follow up to obtain the Good Manufacturing Practices and Quality Control Certificate of companies, along with competent entities. It includes advisement regarding revision and or Standardized Operational Procedures, as well as its practical application, systems of auto-inspection, and validation of processes, procedures and methods.
Its fields of action in other activities are:
Development of Products
|
|
Visanco creates new formulations and provides advisement to the companies in the development of unpublished products in the fields of special purposes, weight control, athlete food products, nutritional supplements, as well as, in the field of drugs based on vitamins and minerals, and herbal medicines.
Laboratory Assays and Analysis of Products |
|
Visanco has partnerships with laboratories, certified by competent entities, to accomplish general laboratory analysis, such as: quality control, stability testing, toxicological and clinical assays, bioavailability/bioequivalence testing and pharmaceutical equivalence testing.
Human Resources Development |
|
Visanco develops and applies human resources qualification programs in the following themes: interpretation of sanitary legislation, good manufacturing practices and quality control, registration of products, sanitary auto-inspection technology with risk analysis, Hazard Analysis and Control Critical Points System – HACCP, organization of quality control documents, through teaching mechanisms in loco and e-learning.
Food and Nutrition Institutional Programs |
|
Visanco provides advisement to public and private institutions in planning and executing institutional food programs with the purpose to improve the quality and rationalize the supplement of food with nutritional ends. Some examples of these advisements are: the school food program, basic food basket, collective meals, nutrition in health, hospital meals, lactaries, milk banks and enteral nutrition.
Quality Control Management System |
|
It consists on the establishment of procedures and taking of decisions so that the products achieve their quality and identity standards demanded. Quality assurance of drugs embraces: Good Manufacturing Practices and Control (GMPC); organizational structure; validation of processes, procedures and methods; development of human resources and documentation. In the food quality assurance system it is also applied the Inspection System with Hazard Analysis Control Critical Points – HACCP.
Registration of prices of drugs |
|
It consists on a technical strategic advisement to manufacturers, importers and distributors of drugs, which the products are subjected to the registration and monitoring of the prices in the Drugs Regulatory Market Chamber – CMED.
Inclusion of Exceptional and High Cost Drugs and of Specific Programs on the list of the Public Health Attention System |
|
It consists of a technical advisement to drug companies for approval of clinical protocols in order to include exceptional, high costs drugs, and of specific programs on the list of the Brazilian National Health System. It also embraces the preparation of technical and administrative documents, submitting and monitoring mechanisms of the processes, along with the competent entities of the Ministry of Health.
Drugs Standardization in the scope of State and Municipal Secretariats, and Advisement in Public Bid of Drugs Acquisition |
|
It consists of a technical advisement to the pharmaceutical companies for their products standardization and sale, as well as the development of epidemiologic studies directed to the public health attention programs, along with municipal and state Secretariats of Health.
Studies and Market Research |
|
It embraces identification activities of the productive and commercial fields, consumer’s profile, prices, public and private market demands, regulatory analysis, pharmacoeconomy, and the perspective of the market for new ventures.
Products Commercial Representation |
|
It embraces the job development of arrangement and commercial representation, regarding the federal, state and municipal governments, in order to sell new drugs, strategical inputs for health, and medical devices, respecting the current legal mechanisms.
Technology Transfer in Pharmaceutical Products |
|
Technical assistance to official laboratories and drug producers interested in pharmaceutical technology transfer processes referred to technological processes absorption, good manufacturing practices and quality control pre-certification system, as well as, in the elaboration of processes of registration of products along with ANVISA.
Advisement in Advertisement for Products that are subjected to Sanitary Surveillance |
|
Technical instruction for promoting products subjected to Sanitary Surveillance, in order to help the regulated sector, through a previous and critical analysis, in the elaboration of advertising material, including labeling, television advertisements, sites, fliers and other advertising pieces.
|
|
Ed. Monte Carlo, Bl. "A"