Regulatory Affairs

Regulatory affairs is a profession which makes sure that pharmaceutical products and medical devices are developed and marketed in accordance with legislation, reflecting advances in scientific and regulatory requirements. Well-considered regulatory strategies, that take account of the regional and global regulatory landscapes, should be developed to make the most of your product’s intrinsic and designed characteristics, bring your product to market as rapidly as possible and generate data that support your commercial objectives. Effective and timely execution of regulatory strategies requires first-class procedural and publishing knowledge, and accomplished negotiators; whilst marketing approval per se is often the essential objective, the specific terms of the approval and promotional opportunities that follow can make a significant difference to a product’s success in the marketplace.

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