Pharmaceutical Regulatory Affairs is a department in a pharmaceutical company that ensures that its organization complies with all of the regulations and laws pertaining to drug research and development companies. This department works with federal, state and local regulatory agencies on issues affecting drug research and development.
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Pharmaceutical Regulatory Affairs is a department of a pharmaceutical company dedicated to ensuring the safety of a company's pharmaceutical products. In the United States, these departments are governed by rules issued by the U.S. Food and Drug Administration.
The Pharmaceutical Regulatory Affairs department is responsible for ensuring that a company's drug promotion is not false or misleading and that the complete picture of a drug is given to the public. There is a Code of Federal Regulations (CFR) that employees in this area must follow. The significant areas of this code include:
The FDA also issues guidance's for these departments to follow. The guidance's describe the FDA's current thinking on a topic.
With more than a decade of experience in the rigorous FDA and ISO environments, MasterControl has developed an integrated software solution that combines industry best practices with the flexibility to meet the needs of every Pharmaceutical Regulatory Affairs department.
The MasterControl™ quality management suite consists of configurable, easy-to-use, and connected applications for automating, streamlining, and effectively managing document control, change control, training control, audits, corrective/preventive action (CAPA), customer complaints, and other documents- and forms-based quality and business processes under a single Web-based platform. Hundreds of companies worldwide rely on MasterControl to facilitate compliance with FDA regulations (e.g., 21 CFR Parts 11, 210-211, 820, 606), ISO quality standards (e.g., ISO 9000, ISO 13485, ISO 14000, ISO/TS16949), pharmaceutical regulatory affairs and Sarbanes-Oxley Act requirements.
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To learn more about MasterControl and Pharmaceutical Regulatory Affairs, visit MasterControl's Resource Center. The Resource Center offers industry white papers, product data sheets, Q & As, case studies and webinars which provide extensive information for companies seeking new tools for change management.