Quality Assurance

At ICSI, quality assurance is the foundation of our veterinary regulatory services, ensuring every study is conducted with integrity, accuracy, and compliance. By embedding rigorous GCP and GLP standards into our processes, we safeguard data reliability, animal welfare, and the credibility of study outcomes. Through quality assurance, we not only meet regulatory expectations but also drive excellence, consistency, and accountability across every stage of research.

Quality Services

ICSI provides a full range of contract GLP/GCP quality assurance and compliance consulting services for veterinary pharmaceuticals, veterinary health products (VHPs), and medical devices (MDs).

ICSI can operate as part of your existing QAU or as an independently contracted QAU. Whether you need a long- or short-term solution, we will meet your requirements and support your team.

GLP

Study design and compliance integration
Regulatory compliance inspections
Internal quality systems inspections
GLP Auditing

GCP

Study design and compliance integration
Quality assurance auditing/quality control review
Comprehensive study monitoring

TRAINING

On-site training
Webinar training
Customized training modules

Good Laboratory Practice (GLP)

Study Design and Compliance Integration

Facility issues (lighting, HVAC, water supply, pest control, etc.)
Equipment considerations, validation and documentation
Test and Control Article/Item considerations
Personnel training needs
Perform gap analysis of existing quality system
Harmonize SOPs with study quality needs
Develop customized documentation forms

Inspections

Regulatory compliance inspections
Internal quality systems inspections
Provide advice regarding regulatory questions, warnings or identified deficiencies (e.g. FDA Form 483 actions, OECD GLP Accreditation deficiencies) responses
Sponsor assistance with regulatory strategy and requirements
Assist Sponsors/Test Facility/Test Sites during a regulatory GLP inspection with on-site or virtual support

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Auditing Services

Test Facility/Site qualification/ requalification audits
Vendor qualification/ requalification audits
Internal test facility audits
Study audits including in-life phases and data review
Archive audits
Procedural audits
Report and study plan audit

Advancing veterinary medicine with
quality-driven, globally compliant research.

Good Clinical Practice (GCP)

Study Design and Compliance Integration

Facility issues (lighting, HVAC, water supply, pest control, etc.)
Equipment considerations, validation and documentation
Test and Control Item/Substance considerations
Personnel training needs
Perform gap analysis of existing quality system
Harmonize SOPs with study quality needs
Develop and integrate customized documentation forms

QA Auditing/QC Review

Protocol
Raw data and data entry
Clinical study files
Investigator sites, on-site inspection
Statistical review
Final study report and sub-reports
Third party vendors

Study Monitoring

Provision of a Lead Monitor
Protocol writing and review
Site Screening and Investigator qualification
Study set-up
EDC user testing
Real-time in-life phase oversight
Data quality control
Deviation/CAPA management
Study close-out