Project Management Services
• Project Management
• Project Execution Planning
• Schedule Development
• Fast Track Validation/Qualification Scheduling
Interim Manager Services
Interim Department / Team Management:
• Manufactruing Department/Teams (Sterile Filling,
Compounding, Solida, etc.)
• Process and Plan Engineering
Department/Teams
• Validation and Qualification Department/Teams
• Quality Unit Department/Teams
GXP-Compliance
• Business/GMP Process Analysis
• Process Developmentand Improvement
• Standard Operatrion Procedures,
Generation and Update Services
• Quality Manuals,
Generation and Update Services
• GAP Analysis in regard to EU/FDA Requirements
and Expectations
• GXP Trainings and Workshops
Validation Services
• Process Validation
• Cleaning Validation
• Analytical and Sampling Method Validation
• Qualification of Equipment & Utilities
• Verification and Validation
• Re-validation and Re-qualification
• Tracebility Matrices and Risk Analysis
• Validation Documantation,
Reviews, Reports and Summaries
• GAP I and GAP II Assessments
Quality Assurance
• Q-Systems Reviews
Development & Optimization
• Validation Master Plans Generation and Update
Service
• Risk Assessments (GXP, Raw Material, Process,
Cleaning, Utilities, Equipment, etc.)
• Procedures and Documentation Review and
Upgrade Services
• Audit Preparation & Support
• Auditing Services