Quality Assurance Consultancy Services

Our QA professionals provide international consultancy services that assist our clients in meeting and/or exceeding GxP internal, domestic and international regulatory requirements and guidelines.

Our staff has extensive training, knowledge and industry experience in cGLP, cGCP, and cGMP regulations working for the biomedical research, medical device, pharmaceutical, biologics and biotechnology companies. This allows us to offer assistance to our clients throughout the drug development lifecycle.

QA Core Services

Quality System Development

  • Standard Operating Procedure (GLP, GCP and GMP) Development
  • Personnel training on clinical quality assurance topics.
  • Central Medical File (CMF) set-up
  • Auditing Services
    • Clinical Site audits (Pre and Post selection)
    • Vendor audits (Testing labs, Core labs, EDC and Contract Manufacturers)
    • Central Laboratory audits
    • Data management audits
    • Tables and listings audits
    • Qualification audits
    • Quality System audits
  • Clinical Study Report Review
  • Validation Document Review
    • Analytical Methods
    • Cleaning
    • Equipment, Facility and Utilities
    • Software
  • Clinical Study Documents (Protocol, Study Plan, IB, CFR, etc.)
  • Training Services
    • Standard Operating Procedures
    • Regulatory Compliance (GLP, GCP and GMP)
    • Clinical Research Associates
    • Clinical Study Staff
    • PAI Readiness
    • Regulatory Inspection Readiness
  • Assessment/Qualification Services
    • Clinical Research Associates Qualification Assessment
    • Principal Investigator and Study Staff Qualification Assessment
    • Clinical Study Risk Assessment
    • Gap Analysis
  • Excursion Management
    • Deviations
    • Corrective and Preventive Actions (CAPA)
    • Change Controls