our services
GLP QA Services for Medical Device, Toxicology, Pharmacokinetic and Pharmacodynamic, Safety Pharmacology, Avian Toxicology, Vector borne disease, Reproductive Toxicity, Animal lab, Field, and Wildlife, Bioanalytical, and Analytical Studies:
- Pre-award Surveys, Vendor Audit, Qualification Audits for Sponsors, Internal Lab Audit, and Supplier audit
- Quality Management System (QMS) Support
- Agency Inspection Readiness
- Data Quality & Integrity Assessments
- Computer System Validation (CSV) / Computer Software Assurance (CSA)
- Analytical Method Validation and Development
- Equipment Qualification Support
- Training Program Development
- SOP Development & Support
- Regulatory Gap Assessments, CAPA, and Root Cause Analysis
- Archiving
our services
GMP QA Services:
- Quality Management System (QMS)
- FDA Inspection Readiness
- Quality Manual Development
- Quality Agreement Reviews
- Good Documentation Practices Assessment
- Computer System Validation (CSV) / Computer Software Assurance (CSA)
- Risk Management (ICH Q9)
- Supplier/Vendor Qualification Audit
- Internal Quality Audits Management
- SOP Development & Support
- Regulatory Gap Assessments
- Deviation and CAPA Investigation Support
- Root Cause Analysis and Continuous Improvement Plan
our services
GCP QA Services (coming soon):
- Auditing Clinical Trial Sites, Sponsors and Vendors
- Performing Internal Quality System Audits
- FDA Inspection Readiness
- Clinical Trial Quality Oversight
- Computer System Validation (CSV) / Computer Software Assurance (CSA)
- Review Clinical Trail Protocols and Consent Forms
- Supplier/Vendor Qualification
- Essential Documents & Trial Master Files
- Clinical Study Conduct
- Regulatory Gap Assessments
- Deviation and CAPA Investigation Support
- Root Cause Analysis and Risk Management
- Tracking Audit Trend and Quality Matrix