Pharmaceuticals Industry
Regulatory submissions in the pharmaceutical–biotechnology and medical device industry comprise documents and data that are submitted to a regulatory agency to gain approval to market new drugs, biologics and devices. The documentation represents years of research and includes multi-disciplinary information (including preclinical and clinical data) regarding the safety and efficacy of a compound. The regulatory process varies from country to country and involves numerous interactions between the submitting company (sponsor) and the regulatory authority (agency). Many regulatory agencies accept electronic submissions in conjunction with or in lieu of submitting paper.
Read more about this topic: Submission Management, Common Scenarios
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“Whatever I may be, I want to be elsewhere than on paper. My art and my industry have been employed in making myself good for something; my studies, in teaching me to do, not to write. I have put all my efforts into forming my life. That is my trade and my work.”
—Michel de Montaigne (1533–1592)