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Introduction Overview of the evolving role of drug regulatory affairs professionals. The role of drug regulatory affairs professionals has evolved significantly over the past few decades in response to the increasingly complex and global nature of the pharmaceutical industry. Initially focused on ensuring compliance with national regulatory standards, these professionals now play a more strategic …

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Introduction Definition and scope of Regulatory Affairs. Regulatory Affairs (RA) is a critical function within the pharmaceutical, biotechnology, and healthcare industries, focusing on ensuring that products meet all regulatory requirements and standards set by governmental bodies, such as the FDA, EMA, and other global authorities. The scope of regulatory affairs encompasses a wide range of …

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Introduction Overview of the importance of regulatory affairs in the pharmaceutical industry. Regulatory affairs are integral to the pharmaceutical industry, ensuring that drugs are developed, manufactured, and marketed in compliance with regulatory standards to protect public health. Experts in drug regulatory affairs work to secure approvals for new pharmaceutical products by interacting with regulatory agencies …

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Introduction Importance of drug labeling and packaging in the pharmaceutical industry. Drug labeling and packaging play a pivotal role in the pharmaceutical industry by ensuring patient safety, regulatory compliance, and the integrity of the drug product. Proper labeling provides essential information, such as dosage instructions, side effects, warnings, and expiration dates, helping prevent medication errors …

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