GCP Quality Assurance & Medical Affairs Consulting
With more than 25 years of pharmaceutical industry experience and over 15 years in GCP Quality Assurance consulting, I have developed strong expertise across Clinical QA, Medical Affairs, Pharmacovigilance, and related fields.
I deliver both strategic and operational guidance to support clinical development, reduce compliance risks, and drive long-term performance.
Based on risk management approach, I create tailored QA project plans, perform audits, and offer advice on QA and inspection readiness to ensure adherence to GCP, standards and regulations.
My customized support extends to pharmaceutical companies, biotech firms, and CROs, helping them oversee all facets of Clinical Quality Assurance and Medical Affairs operations.
I offer a comprehensive range of services across Clinical Quality Assurance and Medical Affairs:
Clinical Quality Assurance
- Design and implementation of Quality Management Systems (QMS) and associated quality objectives
- Risk based analysis and Development of project-level quality strategies
- Conduct of GCP audits, including vendor qualification audits, Trial Master File (TMF) audits, clinical investigator site audits, Phase I unit audits, and vendor audits
- Delivery of GCP training programs tailored to operational teams
- Inspection readiness support, including gap analysis and mock inspections
Medical Affairs
- Optimization of medical processes and operational efficiency
- Facilitating Early Scientific Engagement and Stakeholder Integration
- Definition and execution of medical strategy, medical tactics and objectives
- Oversight and coordination of clinical management activities to ensure
- Timely delivery of clinical programs with a strong focus on quality and compliance
- Budget planning and management, including annual and long-range forecasting
- Opinion Leader (KOL) management and Key engagement strategies
- Supporting and accelerating medical communication: publication, poster, symposium.
- Contribution to global and cross-functional initiatives
Contact
clairecastellobridoux@gmail.com
Tel: +33(0)6 30 19 26 97
bridgetoquality 