Strategic Quality & Regulatory Excellence for Life Sciences
Over 25 years of specialised experience delivering market access, quality assurance and regulatory compliance across Medical Devices and Global Pharmaceuticals.
25+
Years Industry Experience
ISO 13485
Quality Systems Expertise
MHRA
UK Responsible Person Services
Trusted Regulatory Partner
I provide independent consultancy to medical device and pharmaceutical organisations seeking to navigate complex regulatory environments and achieve successful market access.
From established quality management systems to strategic regulatory advice and UK Responsible Person services, I bring deep industry knowledge to help your products reach market safely, compliantly and efficiently.
Get in TouchServices
Specialised regulatory and quality support to help you achieve and maintain market access across the UK and beyond.
UK Responsible Person (UKRP)
Appointed UK Responsible Person acting on your behalf before the MHRA. Ensuring ongoing compliance with UK medical device regulations and maintaining your place on the UK market.
- MHRA registration & liaison
- Post-market surveillance support
- Regulatory representation
QMS Implementation
Design, build and embed robust Quality Management Systems aligned with ISO 13485 and global pharmaceutical standards — from development through to full deployment.
- ISO 13485:2016 compliance
- Pharmaceutical GMP alignment
- Audit-ready documentation
Strategic Regulatory Advice
Expert guidance navigating complex regulatory landscapes. Market access strategies, regulatory pathway selection and proactive compliance planning across jurisdictions.
- Market access strategy
- Regulatory pathway mapping
- Cross-border compliance
Need a tailored solution for your organisation?
Get in Touch
Ready to discuss your regulatory and quality needs? Complete the form below or connect via LinkedIn.
Quick Response
Enquiries are typically acknowledged within 24 hours. All information shared is treated in confidence.