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Regulatory Affairs And News

 Regulatory affairs is a discipline formed from the need of governments to protect public health by controlling the protection and effectiveness of drugs in areas such as pharmaceuticals, veterinary medicines , Medical devices, pesticides, agrochemicals, cosmetics and complementary medicines and the discovery, research, manufacture and marketing companies responsible for these products. A new generation of practitioners has arisen to deal with these compliance problems for businesses. Most companies, whether major multinational pharmaceutical companies or small, innovative biotechnological companies, have specialized regulatory departments. The success of the regulatory strategy depends less on the regulation than on how it is interpreted, applied and communicated within companies and to outsiders. Regulatory Affairs plays a key role in the pharmaceutical industry and is involved in all stages of drug development and also after the approval and marketing of drugs. Throughout the development phase, pharmaceutical companies must comply with a range of strict rules and guidelines to ensure the safety and efficacy of drugs in humans. In this highly controlled environment, regulatory affairs play a critical role, not only as an interface with health authorities and as a link between various departments within the organization, but also as the lead department in offering strategic advice on extremely difficult decisions over the life of a drug product.  

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