Pharmaceutical, biotech, medical device, diagnostics and other life sciences organizations operate under intense public scrutiny in their pursuit of developing lifesaving healthcare products. Continual increases in regulatory and legal requirements that vary by jurisdiction can also significantly disrupt almost every corner of your business while executing critical research and development (R&D) and other clinical tasks. The price of non-compliance can be extreme from a financial perspective, and can cause a loss in reputational costs as well. With continual disruption and uncertainty in the marketplace, even the best leaders can struggle to make informed decisions and provide direction to their organization.
At Baker Tilly, our team of compliance and ethics professionals take a proactive approach that allows companies to gain knowledge about their current state of compliance and how they stack up against what is coming in the future. This is essential for an industry that tends to be reactive, often struggles with proactive mitigation strategies and, every so often, plays catch up to address non-compliant actions that occurred many years prior. We also understand that the most effective way to adopt a “culture of compliance” is to have compliance and ethics ingrained in the daily tasks of the business. For this reason, we provide guidance on how compliance can proactively work with your business and be viewed as a partner, rather than an overseer.