Regulatory Affairs

A pharmaceutical business's regulatory affairs (RA) department is in charge of getting clearance for new pharmaceutical goods and ensuring that approval is maintained for as long as the business wants the product to be on the market. It acts as a liaison between the regulatory authority and the project team, as well as a channel of communication with the regulatory authority as the project progresses, with the goal of ensuring that the project plan accurately anticipates the regulatory authority's requirements before the product is approved. RA is responsible for staying up to date on new legislation, rules, and other regulatory information. In the creation, inspection, quality assurance, and safety assessment of new and current consumable, medicinal, and diagnostic products, regulatory affairs is a mandatory and necessary effort (both ethically and regulatorily).

• FDA
• Clinical trials
• Food industry
• Pharmaceutical industry
• Medical devices
• In vitro diagnostics
• Biologics and biotechnology