Quality & compliance leadership
Setting up and optimising QA/QC teams, eQMS systems, and regulatory frameworks for life sciences companies across Scotland and the UK.
GMP and regulatory readiness
CE/UKCA, ISO 9001, ISO 13485, MHRA, FDA, and ANVISA compliance consulting — from strategy through to inspection.
Inspection & audit preparation
QMS remediation, inspection readiness programmes, and new product introduction inspection management.
Training & coaching
cGMP training, Lean Six Sigma tools and coaching for QA, QC, and validation teams.
Change control & operational excellence
Global programme management for product launches, supply chain changes, and multi-site operational improvements.
Who do I work with?
- Biotech and MedTech startups developing novel products, devices or services
- Biotech, pharma and medical device companies requiring support in remediation work for failing QMS
- Biotech, pharma and medical device SMEs scaling quality operations
- Companies in Scotland and across the UK seeking audit-ready systems
- Teams needing cGMP, Lean or Six Sigma training and coaching
