Pharma IQ Glossary: Pharmaceutical Regulatory Affairs
Pharmaceutical Regulatory Affairs, or Pharma Regulatory Affairs, refers to the professionals who maintain regulations from within the industry. The pharmaceutical industry is the most regulated of all industries. Regulatory affairs professionals are key, but perhaps overlooked, players in drug development. They are the primary communications link between the company and agencies such as FDA, and they are responsible for keeping up with the increasing scope and complexity of regulations. In the pharmaceutical industry, regulatory affairs professionals have expertise in the legal and regulatory environments, as well as in clinical research protocols.
CMC restructuring: the regulatory implications
September 28 by Pharma IQCritical success factors towards Chemistry, Manufacturing, and Controls (CMC) operational restructuring when faced with regulatory activities.
Emergent regulatory affairs sphere
September 10 by Pharmaceuticals & Biotechnology EditorThe role of regulatory affairs specialists is oft-overlooked, and the industry needs to adapt to stay within regulations.
