The regulatory landscape is fluid, requiring regulatory affairs professionals to continuously monitor and identify pertinent regulatory information. The information must be analysed and interpreted so as to determine its implications to the client organization and any potential impact on the research and development, medicine development process or market access.
A broad view of the regulatory landscape is essential in order to anticipate changes and support the decision-making process.
Regulatory intelligence covers guidance documents, regulations, standards, and international as well as country-specific requirements. When regulatory developments are effectively communicated across relevant departments, companies can respond to changes and their potential impacts more effectively and thereby reduce the risk to their medicinal product development and/or regulatory strategies.