Submission Management - Common Scenarios - Pharmaceuticals Industry

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.

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