I’m a GCP Global Pharmaceuticals Consultant (Good Clinical Practice) working in the clinical industry since 2002 and as an auditor since 2005. I have experience of working across twenty countries and systems CROs, SMO’s and MHRA.

I am proficient in GVPV (Good Pharmacovigilance Practice), ISO 9001 Quality Management Systems and ISO 14155. I am a member of RQA, Committed to Sustainable Development Goals and whilst I am UK based, I serve clients internationally.

I hold a BSc (Hons) Biochemistry and tutor modules on MSc Evidence-Based Health Care (Clinical Trial Management) and MSc Quality Management in Scientific Research and Development (Ethics and Regulatory Framework).

Training courses attended include:- The Auditing Course RQA | Practical GCP Compliance Auditing of Trials & Systems DIA | Good Clinical Practices | Advance GCP Skills and Techniques Nortons Audits, Inc (NAI) | Pharmacovigilance Audits and Inspections DIA (Drug Institution Agency) The New MHRA GCP Guide Offer RQA | Computer Systems Validation RQA

19 years GCP auditing experience covers Investigator Site Audits, Trial Master File Audits, Pharmacovigilance Assessments, Process/System Audits and Vendor/CRO Audits. Services include:

1. Audit – includes gap analysis or vendor audits (for auditing supplies) – 3 days.
2. Mock Inspection-3 days – staff readiness (1/2 day).
3. Consultancy and retained services for quality Assurance.
4. Training – Clinical Practise – informed consent.

1. Over 22 years of knowledge and experience in inspection GCP and Audit.
2. A high standard and quality of bespoke service.
3. Someone integrous in character, encouraging and who works with a can-do attitude.
4. Someone who can show you how to build reputation, systems and become a market leader.
5. Information to meet compliance and regulations guidelines for the inspectorate.