Life Sciences companies have to address a growing range of regulatory requirements that spans various geographies, business actives, and functions to create and introduce new products. Although this industry has maintained a steady growth rate and progress by developing agile enforcement and business strategies adaptable to changing legal landscape, it still faces challenges in achieving overall efficiency and compliance. Traditionally, life science organizations have approached compliance by focusing on the organization’s or business functions’ individual needs, resulting in a fragmented approach with each sector creating its own compliance agenda. The subsequent outcome is also a disjointed business environment in the age of Big Data, where data security is at odds with demands for greater accountability.
According to a recent survey, 43 percent of respondents do not believe that current compliance monitoring and reporting systems allow them to prevent or minimize the impact of non-compliance. In comparison, only 19 percent have access to systems that can provide more granular information on specific issues upon request. In an ideal world, a single enterprise-wide system will handle various goods for various purposes. Given the vastly superior data processing capabilities powered by the cloud, artificial intelligence (AI), and robotic process automation, as well as the increasingly growing amount of real-world data produced by IoT devices, there is a lot of room for such systems to improve and play a significant role reshaping the future. However, this would also mean that regulators such as the Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) would have to tighten their hold on the life science industry, lengthening approval times and complicating auditing.
Players in the life sciences industry have established specialized needs to meet the challenges they face in pursuing quality concerns and regulatory standards, and patient safety and accountability. Because compliance is the foundation of product development and commercialization, following a company’s framework to secure qualification for patients and realize commercial objectives has never been more critical.
To this end, many innovative companies have risen, promoting strategies and services that help overcome these challenges while also enhancing overall market growth, enforcement, and efficiency. To help life sciences organizations select the most effective compliance solution provider for their business-specific needs without breaking a sweat and achieve all their long-term business goals, we are glad to present the “Top 10 Life Sciences Compliance Solution Providers - 2021.”