Tag Archives: Regulatory Affairs

Building Regulatory Affairs: Efficiency Quadrant that Drives Spend

Best Practices, LLC has recently completed “Benchmarking Regulatory Affairs Staffing & Performance Excellence in Medical Devices,” a new operational benchmarking study.  After analyzing the data and probing the experience of 30 regulatory affairs (RA) organizations from large and complex companies

Pharma Companies Feeling the Heat From the Sunshine Act


Last week marked the release of the initial data from the Sunshine Act law of the Affordable Care Act, which had been dreaded by many health care professionals and pharmaceutical and medical device executives. So, for the past few years,

Cutting Costs While Ensuring Quality & Safety in Medical Device & Diagnostics Companies


One of the greatest challenges that Medical Device & Diagnostics companies face is ensuring that their products meet the high quality standards that are required at every stage of the product lifecycle, while also holding down costs. As budgets continue

Looking Towards the Future of Regulatory Affairs Within Medical Device Companies


In order to keep up with all of the global regulations and laws pertaining to marketing medical device products, Regulatory Affairs groups must remain efficient and effective in order to be productive. Understanding the expected future trends of the function

The ABCs of Building a High-Impact Global Medical Affairs Function


Maintaining a strong Medical Affairs function is challenging, as they are often plagued by limited resources, personnel turnover, and a rigorous regulatory environment. Despite the vast challenges presented by the clinical development, market education, and regulatory compliance areas, the function