A: The regulatory landscape is becoming significantly more complex, especially as lab test results make up about 80% of the data in regulatory filings. Global shifts like IVDR in Europe and evolving LDT policies in the US have introduced new challenges around compliance, timing, and operational planning. Where sponsors once worked with a single lab, they may now need several to meet country-specific requirements. These changes require deeper collaboration and earlier strategic planning. My focus is on translating new regulations into scalable, compliant processes that support our partners to keep pace with the industry's evolving needs.