Regulatory Affairs and Intellectual Property Rights

From the application of new products to the research and development of new treatments, regulatory affairs play a critical role in the pharmaceutical industry. It plays a variety of roles in the production of pharmacological products. In the pharmaceutical sector, regulatory affairs are similar to vehicle inspectors in the automobile industry. To put it another way, regulatory affairs exist to safeguard public health by assessing the processes of drug research, production, and promotion of pharmaceutical products. Regulatory affairs in the pharmaceutical sector encompasses a wide range of responsibilities. One of these responsibilities is to keep up with changes in pharmaceutical medication research, manufacturing, and marketing legislation.

A legally enforceable right to exclude others from applying the information generated or to determine the terms on which it can be used is known as intellectual property. IP rights are legal and institutional frameworks for protecting mental creations such as inventions, works of art and literature, and designs. They also use marks on products to distinguish them from comparable products marketed by competitors.

• Regulatory inspections, guidance and technologies
• GMP, CMC