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. He works with clients across the product lifecycle, from early development decisions through marketing authorisation and into post-market obligations.

His work spans marketing-authorisation pathways and EMA, MHRA and FDA procedures, market access, GCP and GMP compliance, EU MDR and IVDR for devices and diagnostics, and product safety, recalls, and incident response. He focuses on translating complex requirements into practical steps that product, quality, and regulatory teams can act on.

Scott works closely with clients facing inspections, audits, and time-critical regulatory decisions, translating complex requirements into defensible, practical action.

Scott contributes to the EU life-sciences regulatory community and supports knowledge-sharing across the sector. [Add specific memberships, board roles, or speaking engagements here.]