Former FDA, Industry Leaders Launch Canal Row Advisors to Provide Clients With Strategic Insight And Actionable Guidance In An Increasingly Complex Regulatory Landscape

Core Insights - Canal Row Advisors is positioned to assist life science leaders in navigating the complexities of FDA regulations and policies, leveraging the extensive experience of its founding team [1][4] - The company offers a multidisciplinary approach to support drug and biologics sponsors across various therapeutic areas and technologies, emphasizing a commitment to public health [1][4] Company Overview - Canal Row was founded by four former FDA and industry leaders, each bringing significant expertise in regulatory affairs, compliance, and public health [1][3] - The team includes Michael Rogers, Hilary Marston, Brian Corrigan, and Maura Norden, who collectively have decades of experience in FDA operations and regulatory strategy [3] Services Offered - Regulatory & Clinical Strategy: Canal Row shapes strategies for product advancement from pre-filing through approval and post-market, focusing on regulatory strategy and clinical trial design [3] - Quality & Compliance: The firm identifies opportunities to enhance compliance and quality practices, including inspection readiness and corrective action plans [3] - Regulatory Policy: Canal Row provides clients with up-to-date regulatory intelligence and assists in shaping FDA policies to promote public health [3] - Advisory Services: The company offers specialized regulatory insight and analysis to companies, investors, and law firms, including regulatory diligence and competitive landscape analysis [3]