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QUALITY&GMP DEVELOPMENT&OPERATIONS DUE DILIGENCE MANUFACTURING OUTSOURCING CASE STUDIES

Our Mission | Our Approach | Areas of Services | Advantages



Areas of Services
 
 
Evaluation
 
GMP & QSR Auditing
Contract Manufacturing
Quality System Productivity
Organization and Qualifications
Due Diligence
FDA Preparation & Mock Audits
Risk Analysis
 
 
 
Planning
 
Quality Plan
Compliance Master Plan
Validation Master Plan
Management Action Plan
 
Crisis Management (Strategy & Support)
 
FDA Issues
Emergencies
Negative Trends
Product Quality
Emerging Problems
 
 
Laboratory Support
 
Method Validation
Method Transfer
Laboratory Operations
GMP Compliance
Records
 
 
Validation
 
Validation Master Plan
Process Validation
Packaging Validation
Cleaning Validation
Equipment IQ,OQ, PQ
Test Method Validation
 
 
Documentation
 
Quality Systems & Procedures
Specifications
Master Records
Systems
Templates