Resource Savings Through Effective Global Trade Compliance In Drug Development

By Stacie Phillips, JD General Counsel, Corporate Secretary; Mariesa Coppola, JD Vice President, Deputy General Counsel, Compliance Officer; andSwarna Shreenivas, Legal & Compliance, Senior Counsel III, Curia Global, Inc.

In the intricate landscape of (bio)pharmaceutical development, international trade compliance is a critical factor influencing the success of therapeutic products and medical devices. Partnering with a full-service Contract Development and Manufacturing Organization (CDMO) offers expertise that spans the entire lifecycle of drug development.

From addressing early-phase challenges to ensuring seamless tech transfers and meeting stringent regulatory guidelines, a reliable CDMO is essential for navigating global compliance complexities. The increasing global trade of pharmaceutical products highlights the need for (bio)pharmaceutical companies to be well-versed in international trade requirements. This white paper explores the impact of factors like the COVID-19 pandemic on global trade, emphasizing the importance of a robust international trade compliance program.

Beyond mitigating risks of governmental investigations and penalties, a well-established compliance program becomes a strategic advantage, fostering comprehensive supply chain and cost management for drugs and medical devices. Collaborating with a CDMO equipped with a dedicated trade compliance team ensures consistent planning, accurate cost estimation, and enhanced delivery timelines for materials shipped across borders.

Download our white paper to gain insights on:

• Strategies to mitigate the risks of governmental investigations and penalties through a robust international trade compliance program.
• The increasing importance of (bio)pharmaceutical companies being well-versed in international trade requirements and the impact of global events, such as the COVID-19 pandemic, on trade dynamics.
• The pivotal role of a full-service CDMO in overcoming early-phase challenges and ensuring seamless tech transfers for (bio)pharmaceutical development.
• The strategic advantage of a well-established compliance program in fostering efficient supply chain management and cost control for drugs and medical devices.