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Regulatory area in the pharmaceutical industry
One of the basic rights of the human being concerns the respect to health, which is validated by the Health World Organization.
In Brazil the Anvisa, National Agency of Sanitary Monitoring, has as responsibility to promote health protection to the population through the sanitary control of production and commercialization of products and services submitted to sanitary monitoring qualification.
It is the pharmaceutical industries duty to rigorously observe the quality and security of the products and processes involved in the production. Striving to answers in an efficient way the determinations and norms from the Good Practices of Manufacture of the Health World Organization. Neo Química counts on specific areas, amongst them the department of Regulatory Matters.
This area has the responsibility to inform on the legal and scientific requirements and restrictions, collect, compare, and evaluate given scientific data. Moreover, it takes care of the presentation of specific documentation to regulatory agencies, assuring that the information submitted to the regulatory authorities comply with the legal requirements.
The interchange between regulatory agencies and the products registration control is also made by the Regulatory Matters, being of great importance for the industry.
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