Service Catalogue
✎ Audit Services ✎
Industry Expertise │ GLP │ GCP │ cGMP │ ISO │ 9001 │ ISO 14001 │ ISO 13485 │ FDA │ EPA │ OECD │ EU compliance │
GLP Audits
General List:
👉 Study Protocols
👉 All study phases
👉 Standard Operating Procedures (SOPs)
👉 Facilities
👉 Quality Management System
👉 Vendor Assessment
👉 Mock regulatory inspections
GCP Audits
Protocols
IRB
Data
Quality Management System
Vendor Assessment
Mock Regulatory inspections
cGMP Audits
Pharmaceutical manufacturing
Medical Device manufacturing
Internal audit program
Quality Management System
Vendor Assessment
Mock Regulatory inspections
ISO standards
Pre-registration audits and internal audit programs for:
ISO 9001:2008
ISO 9001:2015
ISO 14001:2003
ISO 14001:2015
ISO 13485:2012
Coming soon—ISO 13485:2016
⇲ Consultation Services ⇱
Gap analysis
Regulatory and Standards implementation
Standard Operating Procedures
Creation and review of existing procedures for GLP, cGMP, GCP and ISO 9001, 14001 and 13485.
Quality Management System
Development
Assessment
Optimization
Root Cause Analysis
Investigation
Plan development
Plan implementation
Corrective & Preventive Action (CAPA)
Investigation
Plan development
Plan implementation
FDA Remediation
483
Warning letter
Consent decree
Facility Commissioning
Plan development
Witness of commissioning activities
Execution
Vendor Assessment
Final report generation
Final report review
Validation
Single plan development
Single plan execution
Master Validation Plan development
Master Validation execution
Vendor assessment
Process and Equipment Validation
Plan development
Plan execution
Validation review
Process Improvement
Process assessment
Improvement plan development
Improvement plan execution
Improvement plan review
Assessment of process improvement implementation
🕗 Training Services 🕗
Regulatory and Standards Training
🕗 COURSES:
👉 GLP
👉 GCP
👉 cGMP
👉 ISO:
• 9001
• 14001
• 13485
Additional Training
🕗 COURSES:
👉 Gap Analysis
👉 Root Cause Analysis
👉 Failure Modes Effective Analysis
👉 SWOT Analysis
👉 Cause and Effect Analysis
👉 Value stream mapping
👉 Process analysis and streamlining
👉 Validation processes
👉 Internal auditor training for your staff