Country Road Consulting

We are a boutique consulting firm providing strategic regulatory and drug development advice and support to help our clients get important drug therapies approved and available for the patients who need them. Specifically, we provide-Regulatory submission management, including content generation, project management, and regulatory strategy for IND, NDA/BLA, EUA, pre-meeting BB, complex regulatory responses (IR, etc), and other key regulatory submissions-Drug development strategy, including considerations for building a robust IND/NDA/BLA application, design of early and late phase clinical trials, navigating regulatory requirements and pathways, and interacting with regulatory authorities-Working with teams to tackle complex drug development problems by asking the right questions, gathering key data, creating coherent presentations to guide discussions, leading productive cross-functional meetings, fostering creative thinking and bold decision-making, and driving teams towards consensus on winning solutions-Authoring high-quality regulatory documents across the entire spectrum of the drug development process, from discovery through post-marketing.