Quality-driven approach
Katalyst HealthCares & Life Sciences provides high-quality and comprehensive Quality Control and Assurance support aligned with clinical trial and project requirements. Our quality-driven approach ensures that all clinical trial activities comply with global Good Clinical Practice standards while maintaining data integrity, consistency, and regulatory compliance. All quality and information security systems are independently certified, reinforcing our commitment to excellence across clinical research operations.
Global quality and compliance standards
Our quality framework is aligned with internationally recognized standards and regulatory requirements governing clinical research, laboratory practices, data integrity, and information security. By adhering to these global guidelines, Katalyst ensures that clinical trial processes, documentation, and systems consistently meet regulatory expectations across different regions and regulatory authorities.
Good Clinical Practices (GCP)
Good Laboratory Practices (GLP)
International Conference on Harmonization (ICH)
21CFR Part11
ISO 9001:2008
ISO 27001:2013
ISMS certifications
FDA
EMEA
Quality control & assurance services
Katalyst’s Quality Control and Assurance services are designed to support clients throughout the clinical trial lifecycle. Our structured quality oversight ensures that study conduct, documentation, facilities, and vendors comply with applicable regulatory and procedural requirements. Through systematic audits and reviews, we help identify gaps, mitigate risks, and maintain inspection readiness.
Auditing Service
Investigator Sites
Clinical Trial Facilities/Units
Central Clinical and Analytical Laboratory Sites
Drug Packaging and Distribution Sites
Suppliers/Vendor/Service Providers Sites
Institutional Review Boards (IRB)
Clinical study deliverables audit support
Our quality teams provide comprehensive audit support for key clinical study deliverables to ensure accuracy, traceability, and regulatory compliance. These audits help confirm that essential documents and systems meet protocol requirements, regulatory standards, and sponsor expectations throughout the study lifecycle.
Study Protocols
Informed Consent Form Audit (ICF)
Trial Master File Audit (TMF)
Clinical Database Audit
Clinical Study Document and Report Audit (CSR)
Validation support services
Katalyst offers validation support services to ensure that computerized systems, databases, and clinical trial management processes operate in a controlled and compliant manner. Our validation activities focus on data integrity, system reliability, and regulatory acceptance across clinical research environments.
Computer Systems Validation
Clinical Database Validation
Clinical Trial Management Systems & Process Validation
Regulatory agency inspection support
We support sponsors and clinical research organizations in preparing for regulatory agency inspections by ensuring inspection readiness and compliance. Our teams assist with pre-inspection audits, documentation review, and staff training to help organizations confidently respond to regulatory inspections and inquiries.
Regulatory Agency Inspection Support
Support for FDA, MHRA, and other global agencies Inspection Preparation (Pre-Agency Audit)
Support for FDA Inspection – Routine & For Cause Audits
Training for any Agency Inspection
Katalyst HLS is specialized in Quality and validation (cGxP) and We provide services and resources to Pharma, Biotech, and Medical Devices research and development and as well as manufacturing.
cGxP (GMP/GLP/GCP/GDP)
Quality Systems Management
Quality Assurance
Compliance/CAPA Management
Quality Systems Audit Services
21 CFR part 11 & GAP Assessments
Katalyst HLS provides best-in-class staffing and recruiting support to all Quality & Validation Projects.
Facilities & Utilities (HVAC, Water, Gases) Validation
Equipment Validation
Laboratory Instruments Validation
Computer Systems Validation
Process Validation
Cleaning Validation