Quality & Validations

Katalyst HealthCares & Life Sciences provides high-quality and comprehensive Quality Control and Assurance support to your project needs. We ensure that all aspects of your clinical trials are in full compliance with Global Current Good Clinical Practice Standards. We are a quality-driven company, and all our systems are independently certified for Quality and Information Security.

• Good Clinical Practices (GCP)
• Good Laboratory Practices (GLP)
• International Conference on Harmonization (ICH)
• 21CFR Part11
• ISO 9001:2008
• ISO 27001:2013
• ISMS certifications

Katalyst’s Quality Control & Assurance Services to clients include:

Auditing Service: (Internal & External)
• 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:
• Study Protocols
• Informed Consent Form Audit (ICF)
• Trial Master File Audit (TMF)
• Clinical Database Audit
• Clinical Study Document and Report Audit (CSR)

Validation Support:
• Computer Systems Validation
• Clinical Database Validation
• Clinical Trial Management Systems & Process Validation

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.

• 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