Regulatory Affairs and Intellectual Property Rights

Regulatory affairs are a field that monitors how foods, pharmaceuticals, and medical devices are produced, tested, manufactured, marketed, and distributed to ensure that they meet regulatory requirements for human consumption. At each stage of product development, regulatory affairs experts are responsible for assuring manufacturers' compliance with applicable global legislative and regulatory standards. Within the healthcare industry, regulatory affairs have a very specific connotation. Its rules govern the production and distribution of safe, effective, and high-quality pharmaceuticals. The pharmaceutical formulation faces new goals and obstacles when new rules are improved and technology is adopted.

• Regulatory inspections, guidance and technologies
• GMP, CMC