Scott McCulloch

Scott McCulloch is the founder of McCulloch Regulatory Compliance, advising biotechnology, pharmaceutical, and medical device and IVD organisations on regulatory strategy and compliance across the EU, UK, US and beyond. With close to two decades of experience across the full product lifecycle, from early development decisions through marketing authorisation and into post-market obligations, he focuses on translating complex requirements into practical, defensible steps that product, quality, and regulatory teams can act on.

Drug Development & Quality Assurance Leadership: Scott advises sponsors on the design of robust quality frameworks across the full product lifecycle, providing high-impact guidance on GCP, GVP, MDR and wider healthcare compliance. He implements and refines Quality Management Systems to meet stringent international regulatory standards, helping clients navigate complex situations through an agile, risk-based approach.

Clinical Oversight & Risk Management: Scott directs strategic oversight within clinical functions using a Quality by Design framework. Working closely with biostatistics and operational colleagues, he identifies Critical to Quality factors and establishes Quality Tolerance Limits to monitor the parameters essential to trial efficiency and data integrity, ensuring systemic risks are identified and addressed through statistical, scientific, and operational oversight. He also mentors cross-functional colleagues to build their compliance and risk-mitigation expertise.

Audit and Inspection Management: Scott directs the strategic execution of global audit programmes, combining technical auditing with executive compliance governance. He manages the complete audit lifecycle, from risk-based site selection and preparation through on-site conduct and reporting, and is experienced in adjudicating findings and managing CAPAs. He leads comprehensive inspection-readiness programmes, including mock inspections and health-authority audits, keeping clinical data and vendor performance robustly defensible.

Clinical Safety & Pharmacovigilance: Scott builds fit-for-purpose global safety infrastructure spanning the product life cycle. During the clinical phase he directs frameworks for expedited SUSAR reporting and ICSR management, supporting independent data-monitoring and safety committees to safeguard participants. For authorised products he establishes pharmacovigilance systems aligned with EMA Good Pharmacovigilance Practices and maintains the PSMF. His post-marketing experience includes signal management, systematic literature monitoring, the production of PSURs, and comprehensive risk-management systems.

Data Privacy: Scott advises on data protection and privacy across the EU and UK, with a particular focus on GDPR compliance for clinical, health, and AI data. He has implemented privacy-by-design programmes, conducted data protection impact assessments, established international transfer mechanisms, and directed breach-response and data-governance frameworks. He holds the CIPP/E (IAPP) certification in European data protection.

Artificial Intelligence: Scott maintains an ongoing academic study of the evolving technology and legal framework surrounding AI, including the implications of text and data mining for AI training and the questions of originality, authorship, and ownership raised by computer-generated works. His work emphasises intellectual-property protections, proprietary data use, and the ethical use of AI (bias, transparency, and accountability) within life sciences.

Scott contributes to the life-sciences regulatory and quality community as a regular speaker and contributor. His recent talks and workshops have addressed:

• Quality and execution in decentralised and data-driven clinical trials, including trial-execution excellence for small and mid-sized biotechnology organisations
• Trial Master File and inspection readiness: regulatory expectations, inspection-readiness workshops, and contributions to European TMF forums
• Data privacy and the use of AI in clinical research, including global compliance benchmarking and the challenges facing smaller biotechs
• Pharmacovigilance system requirements, including the Pharmacovigilance System Master File and GVP Module II