Pharmacist with approximately five years of professional experience and a Master's degree in Research, Development & Innovation, specialized in Regulatory Affairs and Quality Assurance within highly regulated healthcare and medical technology sectors.

I operate at the intersection of compliance and business strategy, transforming complex regulatory frameworks into structured enablers of innovation, market access, and sustainable growth.

By integrating scientific rigor, regulatory foresight, and operational execution, I help companies strengthen compliance, mitigate risk, and deliver safe, high-quality healthcare solutions that truly impact people's lives.

Services

ISO 13485 Audits

ISO 13485 Audits

Independent ISO 13485:2016 audits for medical device manufacturers, distributors, and subcontractors, supporting certification readiness, compliance, and continuous improvement.

Medical Device Regulatory & Quality Consultancy

Medical Device Regulatory & Quality Consultancy

Regulatory and quality support for medical device companies, covering ISO 13485 and EU MDR (Regulation (EU) 2017/745), including QMS implementation, gap analyses, and audit/inspection preparation.

Healthcare & Clinic Quality Consultancy

Healthcare & Clinic Quality Consultancy

Regulatory and quality consultancy for private clinics and hospitals, with a focus on ambulatory services and anaesthesia, ensuring patient safety, regulatory alignment, and inspection readiness.

Audit Strategy & Audit Defence

Audit Strategy & Audit Defence

Guidance on selecting the most appropriate and cost-effective audit approach, preparation for audits and inspections, and professional defence of the audit and its findings towards regulators, inspectors, or third parties, particularly for private clinics.

Contact

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