Halloran Consulting Group

Halloran Consulting Group is a life science consulting firm that provides regulatory, quality, and clinical support to pharma and medical device companies, from early development to commercialization. Its work includes agency interactions, regulatory content, inspection readiness, trial oversight, and organizational strategy.

Regulatory Strategy and Submissions

• Develop regulatory strategies and support agency interactions, including advice informed by frequent FDA engagement.
• Prepare regulatory content such as Module 2 summaries, protocols, and investigator brochures, and support IND, BLA, NDA, and MAA applications. Halloran also provides eCTD document formatting, publishing, assembly, and submission support, reviews CMC filing documents, guides 510(k) applications for medical devices, and serves as an authorized FDA representative.

Quality, Compliance and Inspection Readiness

• Build or assess GxP quality management systems, identify compliance gaps, prioritize risk-based actions, and develop implementation plans, procedures, and CAPA responses.
• Prepare for regulatory inspections through virtual or on-site readiness engagements, conduct GxP audits of clinical vendors and suppliers, and provide support for data integrity, 21 CFR Part 11, and computer system validation.

Clinical Development and Strategy

• Plan and oversee clinical studies through protocol and synopsis development, bottom-up budgets, scenario planning, study start-up, vendor selection, and clinical trial project management for timelines and milestones.
• Evaluate indications and business opportunities through risk, cost, and commercial assessments; support due diligence led by drug development experts and advise on organizational design and change adoption.

Best Fit

• Biopharmaceutical and medical device teams seeking consulting support for regulatory submissions, FDA interactions, GxP quality systems, audits, or inspection preparation.
• Organizations planning or managing clinical studies that need project leadership, study-start-up support, vendor oversight, budgeting, or development strategy.