Dudhope Consulting provides senior QA and regulatory expertise to MedTech, biotech, and pharmaceutical companies. Founded by Dr Gavin Matthew — a Quality and Regulatory professional with over 25 years' experience across the life sciences sector — the consultancy offers pragmatic, experienced support for organisations building, improving, or troubleshooting their quality and regulatory systems
QMS Design and Implementation — Building quality management systems from the ground up, including ISO 9001 and ISO 13485 frameworks suited to the organisation's stage and product type. Regulatory Strategy — Defining and progressing CE marking, UKCA, and other regulatory pathways for novel MedTech and diagnostic products. GxP Compliance and Remediation — Audit readiness, inspection preparation, and targeted remediation for organisations facing compliance gaps.
Quality Function Development — Helping early-stage companies establish effective quality cultures and organisational structures without unnecessary overhead. Interim and Project-Based Support — Flexible senior resource for specific programmes, transitions, or capacity gaps.
- ISO 9001
- ISO 13485
- CE/UKCA certification
- GxP compliance
- Regulatory affairs
- QMS implementation
- eQMS Regulatory inspections (MHRA, FDA, ANVISA)
- Quality culture development
- Supply chain quality
- CDMO/CRO oversight
- Pharmaceutical
- MedTech
- Diagnostics
- Biologics