Quality regulatory writing is the foundation of successful regulatory work. Regulatory professionals must communicate effectively and efficiently to convey complex concepts within tight timelines. The strength and purpose displayed in regulatory writing have an impact on submissions and approvals, documentation for audits, and establishing and maintaining a positive relationship with regulatory bodies. This article explores the fundamentals of regulatory writing and offers...

This article explores the role of a generalist and a specialist within the regulatory profession, as well as considerations in today's evolving regulatory landscape. To decide on the best path forward, it is important to understand current global market expectations from the regulatory profession, as well as compensation depending on job level and education in the healthcare sector.   Keywords – generalist, generalized specialist, professional development, skill set...

Organizations require regulatory intelligence (RI) solutions now more than ever, especially in the current context of rapidly emerging technologies and evolving regulatory landscape. This article provides an overview of a three-part process of RI, consisting of data input, analysis, and output, and its strategic application in the product life cycle and business processes in achieving a competitive edge. RI has a significant range of applications and could be a practical ...

The digital health sector is experiencing enormous growth globally. Briefly, digital health is a branch of healthcare that is primarily focused on improving health using internet, digital, and mobile technologies. One such novel subclass of the digital health ecosystem is digital therapeutics (DTx). DTx are “software-driven,” nonpharmacological therapeutic interventions that can improve the accessibility and effectiveness of healthcare. This article explores the current di...