Information on Regulatory Writing
Regulatory writing is a highly scientific niche that involves the production of documentation required for the approval of drugs by regulatory authorities. The documents are created based on specific templates and guidelines that report the results of clinical trials and are ultimately submitted to the US Food and Drug Administration (FDA). Other national agencies include Health Canada (Canada), European Medicines Agency (EMA) (European Union), and the Ministry of Health, Labour and Welfare (Japan).

Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals.
About Authors:
