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Regulatory translation is the translation of documentation pertaining to the approval and compliance of medical devices, pharmaceuticals and in vitro diagnostics products. Many countries around the world, including Japan and the United States, require that approval dossiers for new products be submitted in local languages for the regulatory bodies to read and analyze.
Regulation is the management of complex systems according to a set of rules and trends. In systems theory, these types of rules exist in various fields of biology and ...
Compliance refers to adhering with the mandated boundaries (laws and regulations) and voluntary boundaries (company's policies, procedures, etc.). [ 9 ] [ 10 ] GRC is a discipline that aims to synchronize information and activity across governance, and compliance in order to operate more efficiently, enable effective information sharing, more ...
Regulatory compliance in the European Union (EU) is governed by a harmonized legal framework designed to ensure consistency across member states while allowing for national implementation. EU compliance regulations cover various industries, including consumer product safety, financial services, environmental protection, and data privacy.
An inspection process or other form of ensuring standard compliance, including reporting and management of non-compliance with these standards; or; The setting of price controls in the form of price-cap regulation or rate-of-return regulation, especially for natural monopolies. Where there is non-compliance, this can result in: Financial ...
Regulatory law refers [1] to secondary legislation, including regulations, promulgated by an executive branch agency under a delegation from a legislature; as well as legal issues related to regulatory compliance. It contrasts with statutory law promulgated by the legislative branch, and common law or case law promulgated by the judicial branch.
Enforcement is the proper execution of the process of ensuring compliance with laws, regulations, rules, standards, and social norms. [1] Governments attempt to effectuate successful implementation of policies by enforcing laws and regulations. [2] Enactment refers to application of a law or regulation, or carrying out of an executive or ...
Regulatory affairs (RA), is a profession that deals with an organization’s adherence to regulatory compliance.. It is a position mostly found within regulated industries, such as pharmaceuticals, medical devices, cosmetics, agrochemicals (plant protection products and fertilizers), energy, banking, telecom etc. Regulatory affairs also has a very specific meaning within the healthcare ...