Quality Risk Management and Regulatory Compliance Support

Service 1

Our Services

  • Quality By Design

  • Quality Risk Management

  • Quality Assurance & Compliance

  • Pharmaceutical Clinical R&D

  • ICH GCP, ICH Q9 & Q10

  • FDA Regulations

  • EU Clinical Trial Directives

  • European Medicines Agency

  • Health Authority Regulations

  • Health Authority Inspections

  • QA Audits & Inspections

  • Audit Plan Development

  • Risk Based Monitoring

  • Due Diligence

  • Pharmacovigilance (Safety)

  • Systems Validation

  • Vendor Management

  • Personnel Management

  • Leadership Development

  • Diversity Management

  • Proactive Management

  • Team Leadership

  • Team Building

  • Organizational Development

  • QA / QC Conceptualization

  • Customer Service

  • Client Needs Assessments

  • LEAN/6 Sigma

  • Process Improvement

  • SOP Development/Quality Manual

  • Strategic Innovation

  • Strategic Planning

  • Research & Analysis

  • Compliance Direction

  • Creative Problem-Solving

  • Conflict Resolution