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Dove Quality Solutions

Dove Quality Solutions is an independent consultancy providing discerning quality management, meaningful risk analysis and high quality audit to reduce the time, cost and impact of quality issues in Clinical Research.  Marrying deep industry expertise and innovative energy to create bespoke quality management and quality assurance solutions which manage and mitigate risk; protecting patient rights, safety and data integrity to deliver successful Clinical Research and Regulatory inspection outcomes.

 

Cathy Dove has a constructive and collaborative approach with over 20 years’ experience in the Clinical Research Quality area including 8 years in global QA/QM executive leadership roles within a large global CRO.  This has provided Cathy with in depth exposure to Pharma, Biotech and Medical Device companies along with significant international (EU,USA and APAC) Regulatory inspection acumen, including a 2 year assignment to APAC based in Singapore.

 

Services

 

Services include, but are not limited to:

 

  • Sponsor/CRO quality oversight audits
  • Regulatory inspection readiness; investigator sites and Sponsor/CRO offices
    • Preparation
    • Management and hosting
    • Post inspection response, issue resolution and remediation
  • Site investigations/for cause audits
  • Quality and Risk Management System review and strategy (ICH GCP E6(R2) requirements)
  • CAPA management process and benefit realisation metrics
  • Creation of risk based audit programs
  • Audits of risk based monitoring
  • Development of Sponsor/CRO Quality Agreements
  • GCP compliance audit as part of merger/acquisition due diligence activities
  • SOP review and development
  • Training and mentoring teams in all of the above

 

Availability for Work

 

Worldwide

 

Areas of Expertise

 

Auditing, Audits-CRO, Audits-CSR, Audits-Company, Audits-For Cause, Audits-Investigator Site, Audits-Phase I-IV, Audits-Process, Audits-Systems, Audits-Vendor, CAPA Management Systems, CRO, CRO/Vendor Qualification and Evaluation, Clinical Safety, Clinical trial audit plans, Coaching, Compliance Remediation, Data Integrity, Due Diligence, GCP Auditing, Good clinical Practice (GCP), Implementation, Improvement, Inspection Preparation, Support and Management, Mock Inspections, Phase 1 facilities, Process, QM Management, QA Systems, Quality Agreements, Quality Management Systems (QMS), Quality Risk Management (QRM), Quality by Design (QbD), Quality Process and Technical Training, Regulatory Inspection-Preparation and Hosting, Regulatory Mock Inspections, Risk Management, Risk-based audit programmes, Standard Operating Procedures (SOPs), Training and Development

Contact Details

1, Langhams Way
Wargrave
Berkshire RG10 8AX
England

Tel: +44 (0) 7516 446246

Email address: enquiries@dovequalitysolutions.com

Website: www.dovequalitysolutions.com

Linked In: https://uk.linkedin.com/in/cathy-dove-79a59813

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