Business processes are the lifeblood that keeps organizations thriving. Yet, not all processes are created equal. Some are straightforward and linear, while others resemble labyrinths with multiple twists and turns. Welcome to the world of process complexity, where the challenges of managing intricate workflows can lead to a cascade of issues that significantly impact operational efficiency and compliance. In this article, we explore the world of complex processes and dive deep into one of the most frequent components of complex processes — approvals. Whether you're navigating the convoluted ..read more

Efficient processes are critical for regulatory affairs teams aiming to bring new drugs to market. However, many organizations still depend on manual, decentralized tools like Excel and Outlook to navigate highly regulated and complex processes. While these tools may appear cost-effective and familiar, they pose practical challenges when applied to Investigational New Drug (IND) and New Drug Application (NDA) processes. These challenges can ultimately impede progress and lead to delays or regulatory consequences ..read more

An efficient publication management process is critical for medical affairs teams tasked with bringing a drug to market. Yet, many companies continue to rely on decentralized tools like Excel and Outlook to manage key aspects of this process. While these familiar tools might seem low-risk and affordable, they come with practical challenges that can hinder growth and compliance risks that could result in delays or penalties ..read more

The world of drug development is evolving rapidly, and nowhere is this more apparent than in the realm of accelerated approvals ..read more

Medical information request management is undoubtedly one of the most important functions of medical affairs teams that operate within the life sciences space ..read more

Publication management is a critical function intended to facilitate the timely and efficient dissemination of valuable research data. However, medical affairs teams often face significant pressure to streamline their publication management process, especially in light of the rapidly evolving role of medical affairs ..read more

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An adverse event report (AER) is a self-initiated medical report detailing an undesirable clinical outcome associated with a medication or medical device. The reports fall under the umbrella of medical information requests (MIRs), as both are initiated by providers or consumers and are then directed at pharmaceutical companies or medical device manufacturers ..read more

Medical information requests (MIRs) are a crucial part of the healthcare and life sciences industry, allowing healthcare providers to obtain the information they need to provide the best possible care for their patients. However, without an efficient MIR management process, delays and inaccuracies can jeopardize patient safety, regulatory compliance, and a company's reputation ..read more

Space management refers to optimizing productivity within an organization by maximizing the efficiency of space utilization. Space management strategies provide a framework for assessing the availability of space, planning resource allocation, and ensuring that current space utilization practices support an entity’s objectives and goals ..read more