Hurley Consulting Associates

Executive Summary

Hurley Consulting Associates has been a trusted partner in health sciences since 1987, providing integrated drug development services from IND through NDA. The firm's expertise spans nonclinical, clinical, and manufacturing evaluations, with a strong focus on regulatory strategy and submission excellence. A key differentiator is its proprietary gap analysis tool, which helps clients identify and address critical path issues early in development. By combining decades of experience with tailored consulting, Hurley supports biotech and pharma clients in navigating complex regulatory landscapes efficiently. The company's private status allows it to maintain flexibility and deep client relationships, though it limits public visibility into its financial performance and growth trajectory. As the drug development outsourcing market expands, Hurley is well-positioned to capture demand for specialized regulatory consulting, particularly in rare diseases and cell/gene therapies.

Upcoming Catalysts (preview)

• Q3 2026Announcement of a major partnership with a top-20 pharma company for regulatory strategy40% success
• Q4 2026Expansion of services into cell and gene therapy consulting, possibly via new hires or a dedicated practice50% success
• Q2 2026Publication of a white paper or case study highlighting successful NDA submission using gap analysis tool70% success