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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 ...
Pharmaceutical sales representatives or Medical sales respresentatives [1] are salespeople employed by pharmaceutical companies to persuade doctors to prescribe their drugs to patients. Drug companies in the United States spend ~$5 billion annually sending representatives to doctors, [ 2 ] to provide product information, answer questions on ...
In 2009, Pharmalink Consulting established its "Pharmalink Affiliate Network ("PAN Global"), providing local regulatory expertise in over 115 countries worldwide. In 2013, Pharmalink Consulting achieved recognition in both the UK and US as one of the Top 20 "Best Places to Work". [1] [2]
A stringent regulatory authority is a regulatory authority which is: a) a member of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), being the European Commission, the US Food and Drug Administration and the Ministry of Health, Labour and Welfare of Japan also represented by the Pharmaceuticals and Medical Devices Agency (as before ...
As of July 2006 CBER's authority resides in sections 351 and 361 of the Public Health Service Act and in various sections of the Food, Drug and Cosmetic Act. [3]Section 351 of the Public Health Service Act requires licensure of biological products that travel in interstate commerce in the United States.
FDA Building 32 houses the Office of the Commissioner and the Office of Regulatory Affairs. The Office of Global Regulatory Operations and Policy (GO), [1] also known as the Office of Regulatory Affairs (ORA), [2] is the part of the U.S. Food and Drug Administration (FDA) enforcing the federal laws governing biologics, cosmetics, dietary supplements, drugs, food, medical devices, radiation ...
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