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Drug Regulatory Affairs

Meaning

Drug Regulatory Affairs is a specialized professional discipline within the pharmaceutical and biotechnology industries that serves as the critical interface between the company developing a therapeutic agent and the governmental regulatory bodies overseeing its approval. This function is responsible for the meticulous preparation and submission of comprehensive documentation, including preclinical and clinical trial data for new hormonal compounds, to obtain authorization for marketing and distribution. Effective regulatory affairs management ensures that new treatments for hormonal imbalances are introduced to the market in a compliant and timely manner, accelerating patient access to innovative therapies.