For biotech companies, navigating legal and business risks has always come with the territory. But the landscape is shifting—driven by shifting enforcement trends, a new presidential administration, and ongoing economic uncertainty.
In her recent article, Working in the grey: FDA, CMS and data privacy, published by Pharmaphorum, OGC Partner Berry Flynn Cappucci discusses how legal and compliance teams in biotech can stay ahead, including by:
• Adopting a proactive compliance strategy
• Implementing risk assessment frameworks
• Strengthening internal audit and monitoring mechanisms
• Maintaining engagement and transparency with regulatory agencies
Berry Cappucci is Partner with OGC and brings over 19 years of legal experience in the life sciences sector. Berry handles a wide range of issues, including licensing and collaboration transactions; mergers & acquisitions and initial public offerings; government regulation and compliance; clinical trials and data privacy; pharmaceutical development, complex commercial contracts; and corporate governance for sciences companies at all stages.