Regulatory Services Expansion Hurley Consulting specializes in end-to-end regulatory support across nonclinical, clinical, and manufacturing domains, with expertise in preparing datasets, reports, global regulatory submission documents, eCTD and CDISC, and IND through NDA processes. This presents an opportunity to upsell comprehensive submission services to sponsors seeking efficient, integrated regulatory pathways.

Global Market Readiness As an international consulting firm with a 25-year track record in health sciences, Hurley can target mid-market pharma and biotech companies aiming to accelerate global submissions and expedite time-to-market, offering tailored regulatory strategies and market-entry assessments.

Data Analytics Advantage Hurley’s strength in data analyses and integration of nonclinical, clinical, and manufacturing evaluations positions them to offer data-driven decision support, potential collaborations on phase-appropriate study design, and robust submission dossiers that streamline regulatory review.

Small-to-Mid Sized Focus With 11-50 employees and revenue in the 25–50 million range, Hurley is well-suited to pursue mid-tier sponsors and strategic partnerships with larger CROs or consulting firms, offering specialized expertise at a flexible engagement model.

Tech-Driven Delivery Utilizing tools like iCIMS, Google Hosted Libraries, DreamWeaver, Microsoft 365, and CDISC/eCTD capabilities, Hurley can emphasize efficient project management, secure data handling, and scalable submission production to attract clients seeking reliable, tech-enabled regulatory services.