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