Whitepaper: Reshaping Affiliate Models Stay Competitive and Remain Compliant
There is no doubt that the pharmaceutical industry is undergoing a profound shift in the way it operates. Some call this a global gravity shift.
There is no doubt that the pharmaceutical industry is undergoing a profound shift in the way it operates. Some call this a global gravity shift.
As the pharmaceutical industry continues to globalize, operational agility is critical to staying in step with a rapidly evolving regulatory environment without jeopardizing quality and compliance. Regulations have grown increasingly stringent and undergone significant change in the past several years. And data and documentation requirements have become increasingly strict and complex — all along the product development lifecycle.
As the complexities have grown, global regulatory harmonization has helped promote efficiency and reduce unnecessary duplication across markets and regions. But despite efforts to harmonize, there remain very different approaches to drug and device regulation depending on market or region, and the differences can span safety, quality or even administration, technology, or infrastructure.