PHARMACEUTICAL REGULATORY AFFAIRS: INTRODUCTION
Pharmaceutical and Clinical Research Industry is the most regulated among all the industries. Every drug before getting market approval must undergo rigorous scrutiny and clinical trials to ensure its safety, efficacy and quality. These standards are set by regulatory authorities of their respective countries such as FDA in US, Medicine Control Agency (MCA) in UK and Drug Controlling Authority (DCA) in India etc. The monitoring by the pharmaceutical regulatory authorities still continues even after the drug has been approved after the clinical trials and marketed to detect occurrence of any serious side effect when used on large number of people. Pharmaceutical Regulatory Affairs play an important role in meeting these regulatory standards. Pharmaceutical Regulatory Affairs cover the activities by which evidence is established to prove that the product is safe meeting the legal standards assuring the good health of consumers.
Pharmaceutical Regulatory Affairs provide an overview of drug development from clinical trials to marketing to post approval activities. It serves as a primary link between the company and the regulatory authorities. Pharmaceutical Regulatory Services professional should be responsible for keeping up with the increasing scope and complexity of the regulations. They are the main interpreters of the laws and regulation for other member of the company. They should have a good personality with good communication skills and should be well versed with current issues.
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