Category: Life Sciences Compliance

Explore our library of blogs, insights, research papers, and more information on compliance in the life sciences industry.

Guide To Conducting Compliance Gap Assessment To Improve Regulatory Compliance

We perform gap assessments in our daily lives without even realizing it. Take, for example, the simple act of meal planning. When planning a meal, you decide what you will eat, identify the necessary ingredients, check what you already have in your kitchen, and then list the necessary items. A trip to the grocery store […]

The Evolving Role of Compliance Officers in the Life Sciences Industry

“Total penalties from compliance-related violations have surpassed $100 Billion in the last two decades.” Undoubtedly, the role of compliance officers is undergoing a profound transformation in response to the growing regulatory landscape and board scrutiny in the life sciences industry. This industry encompasses pharmaceuticals, biotechnology, and medical device manufacturers, and it goes without saying that […]

A Step-By-Step Guide to Solving Open Payments Disputes

Ensuring adherence to Center for Medicaid and Medicare Services (CMS) requirements and maintaining transparency is important for life sciences companies. One critical aspect that demands attention is the correction and resolution of open payments disputes that are initiated by physicians, non-physician practitioners (NPPs), teaching hospitals all of which are collectively referred to as “covered recipients.” […]

The 7 Elements of An Effective Compliance Program

As a compliance professional, you navigate a complex web of laws, regulations, and ethical considerations daily, safeguarding both your company’s reputation and the well-being of patients and consumers. But what makes a compliance program truly effective? How can you ensure that your efforts not only meet the necessary standards but also contribute to the growth […]

The Facts About Open Payments Data in 2024

The publicly accessible information about the payments and transfers of value (ToV) made by reporting entities to covered recipients is known as Open Payments data. The regulatory authorities have made it mandatory for life sciences companies to track and record their financial interactions with healthcare providers and submit the data to the Center for Medicare […]

The Importance of Compliance In The Pharmaceutical Industry

Navigating the Shifting Tides of Pharmaceutical Compliance: Embracing Change for a Data-Driven Future Today, we’re diving deep into the heart of what makes the pharmaceutical compliance industry tick. As US-based compliance professionals, you’re the unsung heroes, the guardians of ethical conduct, and the gatekeepers of patient safety. Strap in, because we’re about to take you […]